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Evidence in practice.


?Clinical question: For a patient with type 1 diabetes type 1 diabetes
n.
See diabetes mellitus.
 and a heel ulcer, could the addition of electrical stimulation to standard wound treatment improve wound healing wound healing Physiology The repair of a wound Steps Inflammation, repair and closure, remodeling, final healing; repair of incisions may be either simple–'clean' wounds with little loss of tissue heal by 'primary intention', or 'dirty' wounds heal by  over standard wound treatment alone?

The purpose of "Evidence in Practice" is to illustrate the literature search process to obtain evidence that can guide clinical decision making. This article is not a case report. The examination, evaluation, and intervention sections are purposely abbreviated.

A 68-year-old man was referred to our facility by his family doctor for treatment of a diabetic ulcer on his left heel that had been present for 6 weeks. He had been diagnosed with type 1 diabetes mellitus type 1 diabetes mellitus Brittle DM, insulin-dependent DM, juvenile-onset DM Endocrinology A severe form of DM caused by ↓ endogenous insulin production by the pancreas, which comprises +– 10% of DM Clinical Extreme hyperglycemia, lability of glucose  at 8 years of age. Five years ago, he underwent a transtibial amputation amputation (ăm'pyətā`shən), removal of all or part of a limb or other body part. Although amputation has been practiced for centuries, the development of sophisticated techniques for treatment and prevention of infection has greatly  of his right leg because of an infected diabetic ulcer on his right heel. He now uses a transtibial prosthesis A transtibial amputation (sometimes one sees transtibal amputation) is an amputation above the foot but below the knee.

Transtibial amputees have the greatest hope of regaining normal mobility.
 and a cane for ambulation am·bu·late  
intr.v. am·bu·lat·ed, am·bu·lat·ing, am·bu·lates
To walk from place to place; move about.



[Latin ambul
. He stated that, since his amputation, he has been diligent with his foot care, which consists of daily visual inspection (for redness, inflammation, and wounds), moisturizing following showering, and callus callus: see corns and calluses.
callus

In botany, soft tissue that forms over a wounded or cut plant surface, leading to healing. A callus arises from cells of the cambium.
 and nail trimming. Despite his rigorous attention to his foot, he developed an ulcer on his left heel, which has been resistant to standard wound treatment (debridement Debridement Definition

Debridement is the process of removing nonliving tissue from pressure ulcers, burns, and other wounds.
Purpose

Debridement speeds the healing of pressure ulcers, burns, and other wounds.
, dressing changes, and off-loading). (1) He was using Lantus * (daily) and Humalog ([dagger]) (with meals) to control his diabetes, Accupril ([double dagger double dagger
n.
A reference mark () used in printing and writing. Also called diesis.

Noun 1.
]) for his hypertension, and the antibiotics Cipro ([section]) and Amoxicillin amoxicillin /amox·i·cil·lin/ (ah-mok?si-sil´in) a semisynthetic derivative of ampicillin effective against a broad spectrum of gram-positive and gram-negative bacteria.

a·mox·i·cil·lin
n.
. ([parallel])

The patient reported decreased "feeling" in his left lower extremity lower extremity
n.
The hip, thigh, leg, ankle, or foot. Also called inferior limb, pelvic limb.
 and was concerned about the prospect of having another amputation. He did not appear to have an active systemic infection [Systemic infection] MORE ABOUT SYSTEMIC INFECTIONSis a generic term for infection caused by microorganisms in animals or plants, where the causal agent (the microbe) has spread actively or passively in the host's anatomy and is disseminated throughout several organs in different : when asked, he said that he had no recent nausea, fever, vomiting, or fatigue. His vital signs were all within normal ranges: body temperature of 37.1[degrees]C, heart rate of 72 beats per minute beats per minute Cardiac pacing The unit of measure for the frequency of heart depolarizations or contractions each minute–or pulse rate , respiratory rate respiratory rate,
n the normal rate of breathing at rest, about 12 to 20 inspirations per minute.

systemic inflammatory response syndrome A term that '
 of 14 breaths per minute, and blood pressure of 128/78 mm Hg. The patient's body mass index was 31 kg/[m.sup.2], indicating that he was overweight. Examination of the foot and lower leg revealed no problems with skin coloration col·or·a·tion  
n.
1. Arrangement of colors.

2. The sum of the beliefs or principles of a person, group, or institution.
 and skin integrity, a cool foot skin temperature (29[degrees]C; normal foot skin temperature is approximately 34[degrees]C), and a weak dorsal pedal pulse on palpation palpation /pal·pa·tion/ (pal-pa´shun) the act of feeling with the hand; the application of the fingers with light pressure to the surface of the body for the purpose of determining the condition of the parts beneath in physical diagnosis. . There were no signs of lower-extremity edema edema (ĭdē`mə), abnormal accumulation of fluid in the body tissues or in the body cavities causing swelling or distention of the affected parts. . These findings are consistent with reduced perfusion of the lower extremity.

Lower-leg and foot sensation was assessed using Semmes-Weinstein monofilaments. Sensation in the foot was altered as follows: plantar plantar /plan·tar/ (plan´tar) pertaining to the sole of the foot.

plan·tar
adj.
Of, relating to, or occurring on the sole.
 and dorsal foot sensation was absent when the 10-g monofilament monofilament,
n a single strand of untwisted synthetic material such as nylon; used to create surgical sutures.

monofilament 
 was used and present when the 75-g monofilament was used, and lower-leg sensation was absent when the 1-g monofilament was used and present when the 10-g monofilament was used. Patients who can detect the pressure associated with the 10-g monofilament have intact protective sensation, which is the ability to detect forces that often result in tissue injury. (2) An inability to perceive the 10-g monofilament indicates a loss of protective sensation and is associated with an increased risk of ulceration ulceration /ul·cer·a·tion/ (ul?ser-a´shun)
1. the formation or development of an ulcer.

2. an ulcer.


ul·cer·a·tion
n.
1. Development of an ulcer.

2.
. (2)

The ulcer was located on the lateral plantar surface of the left heel and was circular, measuring 1.5-cm wide and 0.4-cm deep. The base of the wound consisted of granulation tissue Granulation tissue
A kind of tissue formed during wound healing, with a rough or irregular surface and a rich supply of blood capillaries.

Mentioned in: Granuloma Inguinale

granulation tissue,
n
, and no deeper structures were exposed. The wound had a slow serosanguineous drainage; however, no other drainage or odor was observed.

The patient's home had one set of stairs with 2 railings, and he required his wife's assistance when ascending the stairs because he was unstable. Otherwise, he was independent in the home. The patient indicated that, outside the home, he felt "off balance" when ambulating on uneven surfaces such as the lawn. His inability to drive limited his community independence.

We believed the heel wound was caused by prolonged loading of the posterior heel that went unnoticed because of the patient's decreased sensation to pain and pressure. Furthermore, we thought that decreased perfusion, as evidenced by his diminished dorsal pedal pulse, contributed to the delayed healing. Because of the patient's previous amputation, we were very concerned about healing this ulcer. Our goal was to provide an effective treatment to heal the wound and prevent the patient from undergoing another amputation. We decided to look for and analyze the evidence related to electrical stimulation (ES) as an adjuvant therapy Adjuvant therapy
A treatment done when there is no evidence of residual cancer in order to aid the primary treatment. Adjuvant treatments for endometrial cancer are radiation therapy, chemotherapy, and hormone therapy.
 because our clinical experience suggested that the addition of this modality to the standard wound treatment of debridement, dressing changes, and off-loading may enhance healing rates of diabetic ulcers.

* Databases used for search: CINAHL CINAHL Cumulative Index to Nursing and Allied Health Literature , EBM EBM Evidence-Based Medicine
EBM Electronic Body Music
EBM ecosystem-based management
EBM Evidence Based Medical (statistics)
EBM Environmentally Benign Manufacturing
EBM Expressed Breast Milk
EBM Executive Board Meeting
 Reviews-Cochrane Central Register of Controlled Trials, EBM Reviews-Cochrane Database of Systematic Reviews, and MEDLINE The online medical database of the U.S. National Library of Medicine (NLM) whose parent is the National Institutes of Health, Bethesda, MD. MEDLINE contains millions of articles from thousands of medical journals and publications. The consumer section of the site (http://medlineplus.  (1966-December Week 3 2002)

We performed a combined search of the Cumulative Index to Nursing and Allied Health (CINAHL), the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and MEDLINE by accessing OVID (www.ovid.com) (#) through our university's health science library system. OVID is a vendor that provides access to over 90 databases, and it enables searches of several databases at one time. We decided to use this simultaneous search feature in OVID, which allowed us to complete a comprehensive, efficient search.

CINAHL (www.cinahl.com) is a database that covers the literature related to nursing and the allied health professions, including physical therapy. Because over 1,200 journals are indexed and updated weekly in CINAHL, using this database broadened our search. Furthermore, nurses are often involved in wound treatment; therefore, we felt that there might be some information that is geared toward nursing but that might be relevant to our topic. CINAHL is available through many academic institutions and health care facilities, but if requires a subscription.

OVID lists several reputable evidence-based medicine evidence-based medicine Decision-making 'The use of scientific data to confirm that proposed diagnostic or therapeutic procedures are appropriate in light of their high probability of producing the best and most favorable outcome'. See Meta-analysis.  (EBM) databases, under the heading "EBM Reviews," that include only peer-reviewed articles. One of these databases is the Cochrane Central Register of Controlled Trials. We decided to include this database in our search because it contains over 300,000 bibliographic references to controlled trials published in health care journals, including international sources. These trials are peer-reviewed by contributors to the Cochrane Collaboration The Cochrane Collaboration was developed in response to Archie Cochrane's call for up-to-date, systematic reviews of all relevant randomized controlled trials of health care.  to ensure that only reports of randomized controlled trials or controlled clinical trials controlled clinical trial,
n a research strategy that calls for two samples: an experimental sample of patients receiving a pharmaceutical, and a second sample of control patients receiving a placebo.
 are included. The Cochrane Central Register of Controlled Trials is part of the Cochrane Library The Cochrane Library is a collection of databases in medicine and other healthcare specialties provided by the Cochrane Collaboration. At its core is a database of systematic reviews and meta-analyses which summarise and interpret the results of high-quality medical research. .

The other EBM Reviews database that we searched was the Cochrane Database of Systematic Reviews. This database contains the full text of the regularly updated systematic reviews on the effects of health care prepared by the Cochrane Collaboration. The abstracts of Cochrane Systematic Reviews are available without charge at www.cochrane.org. Individuals or organizations that want to subscribe to Verb 1. subscribe to - receive or obtain regularly; "We take the Times every day"
subscribe, take

buy, purchase - obtain by purchase; acquire by means of a financial transaction; "The family purchased a new car"; "The conglomerate acquired a new company";
 the Cochrane Library and obtain the full text of the articles and reviews can find the subscription information at that Web site.

The last database that we included in our search was MEDLINE (1966-December Week 3 2002). MEDLINE is produced by the National Library of Medicine. It contains citations and abstracts from journal articles related to many medical fields, including nursing, physical therapy, and dentistry and covers over 4,600 biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 journals published in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  and many other countries. MEDLINE can be accessed for free through PubMed at www.PubMed.gov. Our search was performed on January 7, 2003.

Using the OVID search engine, we clicked on the OVID change database button and then selected the Select more than one database to search tab. We then chose our 4 databases--CINAHL, EBM Reviews-Cochrane Central Register of Controlled Trials, EBM Reviews-Cochrane Database of Systematic Reviews, and MEDLINE (1966-December Week 3 2002)--by clicking the check box next to each database title. We then clicked the Click to Begin Search bat on the left side of the screen. (See Fig. 1.) This brought us to the main search page.

[FIGURE 1 OMITTED]

* Initial keywords: diabet$, ulcer$, electric$ stimulation, heal$

The selection of the keywords reflected the main parts of our clinical question. A good clinical question contains a description of the patient or population, the intervention, the comparison (if used), and the outcome. This style of clinical question is also known by the acronym PICO Pico (pē`kō) [Port.,=peak], island (1991 pop. 15,129), 167 sq mi (433 sq km), Horta dist., in the N Atlantic, one of the central Azores. It takes its name from the volcanic mountain, Pico Alto [high peak], which rises to 7,711 ft (2,350 m). . Using this concept, our keywords were diabet$, ulcer$, electric$ stimulation, and heal$. The $ at the end of a term allows the search to include all of the different endings the word may have. For example, if we only searched diabetic and ulcer, we may have missed articles that included "foot ulcers in individuals with diabetes" because of the different endings of the words.

We searched each keyword individually and then combined the 4 searches by typing in 1 and 2 and 3 and 4 in the keyword or phrase box. Each number corresponded to the line numbers for each term in our search history. Our rationale for combining the keywords was to ensure that the articles that we retrieved contained the information necessary to answer our clinical question. This initial search yielded 25 citations: We then decided to limit our search.

* Limits: human, randomized controlled trial

Because the articles indexed by CINAHL and MEDLINE may not be randomized controlled trials and may use animal models, we decided to use the Limits feature to ensure that we retrieved only articles that were randomized controlled trials with human subjects. To do this, we clicked on the Limits option at the top of the main search screen and selected the human box under the Limit to: section and then scrolled farther down the screen to Publication Type menu, where we selected Randomized Controlled Trials. This narrowed our search to 15 citations, which we were able to review by clicking on the Display button next to the appropriate line in our search history.

* Selection of articles for review: When we scanned the citations generated from our search we observed that 3 citations were retrieved from more than one database. Peters et al [citation 1] was retrieved from CINAHL, EBM Reviews-Cochrane Central Register of Controlled Trials, and MEDLINE; Baker et al [citation 5] was retrieved from CINAHL, EBM Reviews-Cochrane Central Register of Controlled Trials, and MEDLINE; and Lundeberg et al [citation 7] was retrieved from EBM Reviews-Cochrane Central Register of Controlled Trials and MEDLINE. The list of unique citations that were reviewed are shown in Figure 2. Citations 3, 4, 6, 8, 9, and 10 were eliminated because the titles were not directly related to our topic. Of the 4 remaining citations, we did not pursue citation 2 because it was not easily accessible. Therefore, we were able to identify 3 citations (citations 1, 5, 7) that were useful.

On the page displaying the final results of our search, we selected the citations that we wished to keep by clicking on the check box to the left of that citation. Next, we scrolled to bottom of the page and, in the Citation Manager section, we clicked Selected Citations in the Citations menu; from the Fields menu, we selected Citations + Abstract; and from the Citation Format menu box, we clicked OVID and also checked the Include Search History box. We then clicked on Save, which saved the file to our local hard drive for later review.

Peters EJ, Lavery LA, Armstrong DG & Fleischli JG (2001). Electric stimulation as an adjunct to heal diabetic foot diabetic foot A foot with a constellation of pathologic changes affecting the lower extremity in diabetics, often leading to amputation and/or death due to complications; the common initial lesion leading to amputation is a nonhealing skin ulcer, induced by  ulcers: a randomized clinical trial randomized clinical trial,
n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies.
. Archives of Physical Medicine & Rehabilitation, 82, 6, 721-5, Jun.

OBJECTIVE: To evaluate high-voltage, pulse-galvanic electric stimulation as an adjunct to healing diabetic foot ulcers. DESIGN: Randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blind, placebo-controlled pilot trial. SETTING: University medical center. PATIENTS: Forty patients with diabetic foot ulcers, consecutively sampled. Twenty patients each assigned to treatment and placebo groups. Five patients (2 treated, 3 placebo) withdrew because of severe infection. INTERVENTIONS: Electric stimulation through a microcomputer every night for 8 hours. The placebo group used identical functioning units that delivered no current. Additional wound care consisted of weekly debridements, topical hydrogel hy·dro·gel
n.
A colloidal gel in which the particles are dispersed in water.



hydrogel

a gel that contains water.

hydrogel Wound care A polymer absorptive wound dressing. See Dressing.
, and off-loading with removable cast walkers. Patients were followed for 12 weeks or until healing, whichever occurred first. MAIN OUTCOME MEASURES: Proportion of wounds that healed during the study period. Compliance with use of device (in hr/wk), rate of wound healing, and time until healing. RESULTS: Sixty-five percent of the patients healed in the group treated with stimulation, whereas 35% healed with placebo (p = .058). After stratification by compliance, a significant difference was identified among compliant patients in the treatment group (71% healed), noncompliant patients in the treatment group (50% healed), compliant patients in the placebo group (39% healed), and noncompliant patients in the placebo group (29% healed, linear-by-linear association = 4.32, p = .038). There was no significant difference in compliance between the 2 groups. CONCLUSION: Electric simulation enhances wound healing when used in conjunction with appropriate off-loading and local wound care.

[[c] 2001 American Congress of Rehabilitation Medicine rehabilitation medicine Physiatry, physiotherapy A field of therapeutics that bridges the gap between conventional and nonconventional medicine; rehabilitation physicians may adminsiter or prescribe mechanical–eg, massage, manipulation, exercise, movement,  and the American Academy The American Academy in Berlin is a non-partisan academic institution in Berlin. It was founded in September 1994 by a group of prominent Americans and Germans, among them Richard Holbrooke, Henry Kissinger, Richard von Weizsäcker, Fritz Stern and Otto Graf Lambsdorff and opened in  of Physical Medicine and Rehabilitation physical medicine and rehabilitation
 or physiatry or physical therapy or rehabilitation medicine

Medical specialty treating chronic disabilities through physical means to help patients return to a comfortable, productive life despite a medical
. Abstract reprinted with permission from Elsevier Science.]

This randomized, double-blind, placebo-controlled pilot trial demonstrated that ES delivered 8 hours per night resulted in wound healing in 71% of the patients in the treatment group who adhered to the protocol as compared with 39% of the patients in the placebo group who adhered to the protocol. Because our patient was very motivated to heal his wound and because the nighttime treatment would interfere minimally with his daily life, we decided to obtain a copy of the full article from our health science library to examine it further.

Exclusion criteria exclusion criteria AIDS Donor exclusion criteria, see there  for the subjects with diabetes in this pilot study included soft tissue or bone infection, malignancy, or any cardiac conductivity disorder. Our patient was similar to the patients in the study, and he fit the criteria for inclusion in this study. The protective sensation threshold and vibratory vibratory /vi·bra·to·ry/ (vi´brah-tor?e) vibrating or causing vibration.

vibratory

vibrating or causing vibration; vibritile.
 perception threshold of each subject were tested to determine the presence of a neuropathy. Plantar pressures and initial glycosylated hemoglobin gly·co·sy·lat·ed hemoglobin
n.
Any of four hemoglobin fractions that together account for less than 4 percent of the total hemoglobin in the blood.
 blood levels also were measured. There were no significant differences in demographic characteristics between the treatment and the placebo groups. The subjects in the treatment group wore a Dacron-mesh silver nylon stocking ** through which they received nocturnal ES using a Micro-Z device. ** Each hour over an 8-hour period, a subsensory 10-minute dosage of 50 V, with 80 twin-peak, monophasic pulses per second (pps), was delivered, followed by 10 minutes of stimulation at 8 pps, and then a 40-minute rest period. The placebo group wore a similar stocking connected to a similar device, but no electrical current was delivered. No adverse effects were noted.

Based on their findings, the authors concluded that high voltage The term high voltage characterizes electrical circuits, in which the voltage used is the cause of particular safety concerns and insulation requirements. High voltage is used in electrical power distribution, in cathode ray tubes, to generate X-rays and particle beams, to  pulsed current, delivered more than 20 hours per week, may enhance wound healing when used in combination with traditional wound care (debridement, NU-GEL collagen wound gel ([dagger][dagger])), pressure reduction at the site of ulceration, and daily dressing changes. The authors indicated that, although the Micro-Z ES units were donated by the manufacturer, there was no conflict of interest involved in the conduct of this investigation. The article included the following statement: "No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the author(s) or upon any organization(s) with which the author(s) is/are associated."

Although this was a pilot study and the number of subjects was small, we considered the results to be favorable. Electrical stimulation performed as described would be convenient for our patient because the ES would be delivered at night, avoiding disruption of his daily activities.

Baker LL, Chambers R, DeMuth SK, Villar F. Effects of electrical stimulation on wound healing in patients with diabetic ulcers. Diabetes Care. 20(3):405-12, 1997 Mar.

OBJECTIVE: To evaluate the effects of two stimulation waveforms on healing rates in patients with diabetes and open ulcers. The hypothesis was that stimulus waveforms with minimal polar characteristics would provide significant healing for this patient sample. RESEARCH DESIGN AND METHODS: This was a prospective study that enrolled 80 patients with open ulcers. Patients received stimulation with either an asymmetric biphasic bi·pha·sic  
adj.
Having two distinct phases: a biphasic waveform; a biphasic response to a stimulus. 
 (A) or symmetric biphasic (B) square-wave pulse. Amplitudes were set to activate intact peripheral nerves Peripheral nerves
Nerves throughout the body that carry information to and from the spinal cord.

Mentioned in: Amyloidosis, Charcot Marie Tooth Disease
 in the skin. Two other groups received either very low levels of stimulation current (MC), or no electrical stimulation (C). When combined these groups were referred to as the control group. Treatment was carried out daily until the wound healed, the patient withdrew from the study, or the physician changed the overall wound management program. Average healing rates were calculated from weekly measures of the wound perimeter and were used for statistical comparison through a one-way analysis of variance. RESULTS: Stimulation with the A protocol significantly increased the healing rate, enhancing healing by nearly 60% over the control rate of healing. Stimulation with the B protocol did not increase the healing rate when compared with control subjects. CONCLUSIONS: Electrical stimulation, given daily with a short pulsed, asymmetric biphasic waveform, was effective for enhancement of healing rates for patients with diabetes and open ulcers.

[[c] 1997 American Diabetes Association The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of . Abstract reprinted with permission from the American Diabetes Association.]

The abstract suggested that including ES with an asymmetric, biphasic, square-wave pulse with standard wound treatment results in significantly increased healing rates in people with diabetic ulcers compared with standard wound treatment alone. We decided to read the full text of this article in order to more closely review the results of the different ES waveforms used in this study. We obtained a copy of the full-text article from our health sciences library.

All patients in the study had diabetes and were randomized to 1 of 4 groups: group A received stimulation with an asymmetric (n=21), biphasic, square-wave pulse; group B received stimulation with a symmetric, biphasic, square-wave pulse (n=20); group MC received a low level of stimulation current (n=19); and group C received no ES (n=20). The subjects were treated as inpatients (seen 5 days per week by the therapist) or as outpatients (seen weekly in clinic). Patients received ES in addition to their standard wound treatment of dressing changes. Control patients were reassigned to the A or B treatment protocols after 1 month, and their stimulation-treated wounds were counted as new wounds. Thus, a total of 114 wounds were treated, with 17 patients managed for more than one wound, and 5 patients were changed from the control group to a treatment protocol. Patients were followed until: their ulcers healed (45 wounds), the physician decided on another form of treatment (24 wounds), or the patient did not adhere to adhere to
verb 1. follow, keep, maintain, respect, observe, be true, fulfil, obey, heed, keep to, abide by, be loyal, mind, be constant, be faithful

2.
 the protocol (17 wounds) or withdrew from the study (28 wounds). Initial analysis demonstrated no significant difference in mean healing rates among the 4 groups. In addition, as many wounds healed in group A (45%) as in the control group C (48%).

Because there was no difference between the 4 groups and because group MC was designed to be a control group (although the authors stated that the microstimulation that group MC received appeared to have a beneficial effect on wound healing), the authors felt justified in combining groups C and MC into a single control group (CONTROL). They then reanalyzed the data. With this regrouping of patients, a greater healing rate of 10% per week was identified in group A compared with the CONTROL group (27.0 [+ or -] 4.0 vs 17.3 [+ or -] 2.7% per week); however, healing rates in group B (16.4 [+ or -] 6.1% per week)were not different from either group A or the CONTROL group.

Although the patients were unaware of the type of treatment they were receiving, the therapist performing the daily stimulation treatment and weekly wound tracings knew the assignment of each patient, which thus introduced a potential for bias in the data. Although the groups were similar demographically, group A contained patients with wounds of a longer duration (A: 109 [+ or -] 24 days; B: 74 [+ or -] 21 days; MC: 54 [+ or -] 10 days; C: 59 [+ or -] 10 days).

The results reported in this article suffer from reduced validity because the patients were not all analyzed in the original groups to which they were assigned, an intention-to-treat analysis was not carried out despite the high dropout (1) On magnetic media, a bit that has lost its strength due to a surface defect or recording malfunction. If the bit is in an audio or video file, it might be detected by the error correction circuitry and either corrected or not, but if not, it is often not noticed by the human  rates, the primary person collecting the data was aware of the patient assignment (ie, was not "blinded" to group assignment), and the wounds in one group had been present for a longer duration at the start of the study. In addition, some patients in groups A and B used the ES device longer than the 3 periods of 30 minutes per day. As a result, the duration of stimulation ranged from 0.9 to 4.6 hours per day. This range of treatment length makes it impossible to determine an effective treatment duration. We therefore decided not to use this study when making our clinical decision.

Lundeberg TC, Eriksson SV & Malm n. 1. A kind of brick of a light brown or yellowish color, made of sand, clay, and chalk.  M. (1992). Electrical nerve stimulation Electrical Nerve Stimulation Definition

Electrical nerve stimulation, also called transcutaneous electrical nerve stimulation (TENS), is a noninvasive, drug-free pain management technique.
 improves healing of diabetic ulcers. Annals of Plastic Surgery. 29, 4,328-31, Oct.

A controlled study of the effects of electrical nerve stimulation (ENS) was performed in conjunction with a standard treatment for healing chronic diabetic ulcers on 64 patients divided randomly into two groups. All patients received standard treatment (paste-impregnated bandage and a self-adhesive elastic bandage elastic bandage
n.
A stretchable bandage used to create localized pressure.
) plus placebo ENS or ENS (alternating constant current; frequency, 80 Hz; pulse width pulse width Pulse duration Cardiac pacing The duration of a pacing pulse in msecs , 1 msec; intensity-evoking strong paresthesias Paresthesias
A prickly, tingling sensation.

Mentioned in: Autoimmune Disorders
) for 20 minutes twice daily for 12 weeks. Comparison of percentages of healed ulcer area and the number of healed ulcers was made after 2, 4, 6, 8, and 12 weeks. There were significant differences (p < 0.05) in both ulcer area and healed ulcers in the ENS group compared with the placebo group after 12 weeks of treatment. The results of the present study support the use of ENS in diabetic ulcers. ENS is easy to apply and can be used by the patient at home following instructions from a medical doctor or a therapist experienced in electrical stimulation and the treatment of ulcers. Additional studies are needed to identify the mechanisms involved in the promotion of ulcer healing with electrical stimulation and to determine the stimulus variables that most efficaciously accelerate tissue repair.

[[c] 1992 Lippincott Williams & Wilkins. Abstract reprinted with permission from Lippincott Williams & Wilkins.]

According to according to
prep.
1. As stated or indicated by; on the authority of: according to historians.

2. In keeping with: according to instructions.

3.
 the abstract, electrical nerve stimulation (ENS) demonstrated beneficial effects. The protocol differed from the study by Peters et al in the magnitude and duration of ES. Most notably, this intervention evoked strong paresthesias compared with the subsensory stimulation used by Peters et al, and it was applied only 40 minutes per day compared with 8 hours per day by Peters et al. In an effort to further our investigation of different protocols, we decided to obtain the full-text article from our health science library.

In this study, the authors compared the effects of standard wound treatment (a paste-impregnated bandage and a self-adhesive elastic bandage) plus ENS with the effects of standard wound treatment and placebo ENS on the healing of diabetic foot ulcers. The placebo group was treated with the same protocol as the treatment group but without electrical output from the ENS units. The patients were told that "they might experience light sensation, strong sensation, or no sensation at all" and that sensation (or lack of sensation) was not "related to the effects of therapy."

At the beginning of the study, each group contained 32 participants; however, 13 participants (5 from the control group and 8 from the treatment group) withdrew from the study because of allergy, pain, or unspecified reasons (the reasons for withdrawal from the study were not different between groups). The ulcers of 10 of the participants in the treatment group and of 4 of the participants in the control group were healed within 12 weeks. We were surprised by the authors' general description of patients as having "diabetic leg ulcers due to venous stasis venous stasis Medtalk The pooling of venous blood in a particular region which, in the legs results in edema, hyperpigmentation and possibly ulceration " because diabetic foot ulcers are most commonly associated with arterial disease and peripheral neuropathy Peripheral Neuropathy Definition

The term peripheral neuropathy encompasses a wide range of disorders in which the nerves outside of the brain and spinal cord—peripheral nerves—have been damaged.
. We decided that the results of this study might not apply to our patient because his foot ulcer was attributed to a combination of reduced perfusion and neuropathy, not venous stasis.

* Clinical decision: The results of our literature search yielded one small study that was valid and relevant to our patient. Peters et al demonstrated that the Micro-Z ES unit, when used for more than 20 hours per week in conjunction with local wound care and appropriate pressure reduction, may enhance wound healing in patients with diabetes. The participants in the study were similar to our patient in age, sex, and history of diabetes. Based on the review of this evidence and our patient's characteristics and motivation to prevent an amputation, we recommended a trial of high-voltage, pulsed ES for treatment of his diabetic foot ulcer in addition to his standard wound treatment of debridement, dressing changes, and off-loading to protect the injured area from damage-causing pressures. We recommended delivering the ES using the Micro-Z device with the Dacron-mesh silver nylon stocking to provide nocturnal ES. In view of the findings of Peters et al, the ES treatment was planned for 12 weeks--8 hours every night, with each hour consisting of 10 minutes of 50-V simulation with 80 twin-peak, monophasic pulses per second, followed by 10 minutes of stimulation at 8 pps, and ending with a 40-minute rest period. This treatment would be easy for the patient to administer independently at home. The treatment would be delivered at night while the patient was sleeping, avoiding interruption of his daily activities. The ES would be delivered at a subsensory level and, therefore, would not interfere with the patient's sleep.

In conclusion, developing a clinical question, utilizing the question to develop search terms, and searching several databases simultaneously permitted us to efficiently identify 3 useful abstracts. Review of the full-text articles allowed us to identify one small, well-conducted (and thus valid) investigation that used ES as an adjunct to standard wound treatment to aid the healing of wounds in patients with diabetes who were similar to our patient. Although we were able to identify only one study, it was of sufficient quality in our opinion to consider a trial of ES. This evidence, coupled with our patient's desire to utilize all resources available to him to prevent his wound from resulting in an amputation, led us to recommend a trial of ES in combination with standard wound treatment.
Figure 2. Citations Retrieved From OVID Combined Search of CINAHL,
Cochrane Central Registry of Controlled Trials, Cochrane Database
of Systematic Reviews, and MEDLINE Using Keywords "Electric$
Stimulation," "Heal$," "Diabet$," and "Ulcer$" and Limited to
"Human" and "Randomized Controlled Trial"

1. Peters EJ. Lavery LA. Armstrong DG. Fleischli JG.
Electric stimulation as an adjunct to heal diabetic foot
ulcers: a randomized clinical trial. Archives of Physical
Medicine & Rehabilitation. 82(6):721-5, 2001 Jun. *

2. Pham HT. Wound care in diabetic foot ulceration.
Wounds-A Compendium of Clinical Research & Practice.
12(6):Suppl B: 82B-9B, 2000 Nov-Dec. *

3. Gilcreast DM. The effect of electrical stimulation on
foot skin perfusion in persons with or at risk for diabetic
foot ulcers. University of California, San Francisco **
PH.D. (184 p) 1995. *

4. Gilcreast DM. Stotts NA. Froelicher ES. Baker LL.
Moss KM. Effect of electrical stimulation on foot skin
perfusion in persons with or at risk for diabetic foot
ulcers. Wound Repair & Regeneration. 6(5):434-41,
1998 Sep-Oct. *

5. Baker LL. Chambers R. DeMuth SK. Villar F. Effects of
electrical stimulation on wound healing in patients with
diabetic ulcers. Diabetes Care. 20(3):405-12, 1997
Mar. *

6. Claeys LG, Horsch S Transcutaneous oxygen pressure
as predictive parameter for ulcer healing in endstage
vascular patients treated with spinal cord stimulation.
International Angiology. 15(4):344-9, 1996 Dec. ([dagger])

7. Lundeberg TC, Eriksson SV, Malm M Electrical nerve
stimulation improves healing of diabetic ulcers. Annals
of Plastic Surgery. 29(4):328-31, 1992 Oct. ([dagger])

8. McLauchlan, GJ. Handoll, HHG. Interventions for
treating acute and chronic Achilles tendinitis. Cochrane
Musculoskeletal Injuries Group. Cochrane Database of
Systematic Reviews. Issue 4, 2002. ([double dagger])

9. Flemming, K. Cullum, N. Laser therapy for venous
leg ulcers. Cochrane Wounds Group. Cochrane Database
of Systematic Reviews. Issue 4, 2002. ([double dagger])

10. Evans, D. Land, L. Topical negative pressure for
treating chronic wounds. Cochrane Wounds Group.
Cochrane Database of Systematic Reviews. Issue 4,
2002. ([double dagger])

* Retrieved from CINAHL database.

([dagger]) Retrieved from Cochrane Central Register of
Controlled Trials.

([double dagger]) Retrieved from Cochrane Database of
Systematic Reviews.


* Aventis Pharmaceuticals Inc, 300 Somerset Corporate Blvd, Bridgewater, NJ 08807-2854.

([dagger]) Eli Lilly Eli Lilly can refer to:
  • Eli Lilly and Company, a global pharmaceutical company
  • Colonel Eli Lilly (1839-1898), founder of Eli Lilly and Company
  • Eli Lilly (industrialist) (1885-1977), former president of Eli Lilly and Company
 & Co, Lilly Corporate Center, Indianapolis, IN 46285.

([double dagger]) Pfizer Inc, 235 E 42nd St, New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
, NY 10017-5703.

([section]) Bayer Corp, Pharmaceutical Division, 400 Morgan Ln, West Haven West Haven, town (1990 pop. 54,021), New Haven co., S Conn., a suburb across the West River from New Haven; settled 1638, inc. as a separate borough 1873. Although mainly residential, there are diversified manufacturing industries. , CT 06516.

([parallel]) GlaxoSmithKline, 5 Moore Dr, PO Box 13398, Research Triangle Park Research Triangle Park, research, business, medical, and educational complex situated in central North Carolina. It has an area of 6,900 acres (2,795 hectares) and is 8 × 2 mi (13 × 3 km) in size. Named for the triangle formed by Duke Univ. , NC 27709.

(#) Ovid Technologies Ovid Technologies (or just Ovid) is part of the Wolters Kluwer group of companies. It provides access to online bibliographic databases, journals and other products, chiefly in the area of health sciences. , 333 Seventh Ave, 4th Fl, New York, NY 10001.

** Prizm Medical Inc, 3400 Corporate Way, Ste I, Duluth, GA 30096.

([dagger][dagger]) Ethicon Inc, a Johnson & Johnson Company, Rte 22 West, Somerville, NJ 08876.

References

(1) Margolis DJ, Kantor J, Berlin JA. Healing of diabetic neuropathic foot ulcers receiving standard treatment: a meta-analysis. Diabetes Care. 1999;22:692-695.

(2) Birke JA, Sims DS. Plantar senory threshold in the ulcerative ulcerative /ul·cer·a·tive/ (ul´se-ra?tiv) (ul´ser-ah-tiv) pertaining to or characterized by ulceration.

ulcerative

pertaining to or characterized by ulceration.
 foot. Lepr Rev. 1986;57:261-267.

?In the next Evidence in Practice: Julie M Whitman, PT, DSc, OCS OCS - Object Compatibility Standard , FAAOMPT, Julie M Fritz, PT, PhD, ATC ATC Air Traffic Control
ATC Average Total Cost
ATC Certified Athletic Trainer
ATC At the Center (Hartford, Maine retreat center)
ATC Applied Technology Council
ATC All Things Considered
, and Robert E Boyles, PT, DSc, OCS, will seek answers to the question, "Is a continued program of joint mobilization joint mobilization Osteopathy The passive movement of joints over their entire ROM, to expand the ROM and eliminate restrictions. See Osteopathy. , stretching, and mobility exercises effective for improving function in a patient with adhesive capsulitis adhesive capsulitis
n.
See frozen shoulder.


adhesive capsulitis Orthopedics A condition caused by prolonged immobility of the shoulder joint Clinical Shoulder is painful, tender, ↓ passive and active ROM
, or should an alternative approach be used?" (Coming in May 2003)

Stephanie B Grim, Jordan M Duffy, and Peter N Theodosopoulos, MSc, are physical therapist students in the Department of Rehabilitation Science, University at Buffalo, The State University of New York International student enrollment
UB ranks 10th in the United States for international student enrollment, with about 10 percent of UB undergraduate and graduate students being international.
, Buffalo, NY.

Dale R Fish, PT, PhD, is Associate Professor and Associate Dean, School of Public Health and Health Professions, University at Buffalo, The State University of New York.

Patricia J Ohtake, PT, PhD, is Associate Professor, Department of Rehabilitation Science, University at Buffalo, The State University of New York.

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