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Clinical Trial of Footwear in Patients with Diabetes Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Clinical Trial of Footwear in Patients with Diabetes conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Clinical Trial of Footwear in Patients with Diabetes Clinical research trials and Clinical Trial of Footwear in Patients with Diabetes medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Clinical Trial of Footwear in Patients with Diabetes. Clinical Trial of Footwear in Patients with Diabetes Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Clinical Trial of Footwear in Patients with Diabetes clinical trial. Subjects often receive the most expert healthcare possible for their Clinical Trial of Footwear in Patients with Diabetes condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Clinical Trial of Footwear in Patients with Diabetes  Clinical Trial of Footwear in Patients with Diabetes
Clinical Trial of Footwear in Patients with Diabetes
For Condition: Amputations,Diabetes,Lower extremity ulcers
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: A Seattle VA study indicated lower extremity ulcers preceded 84% of diabetic amputations. Nearly half of the events that ban the causal chain leading to ulcers and amputation were initiated by ill-fitting footwear. Other investigators report similar findings for injurious footwear in their diabetic patient populations. Yet, the efficacy of footwear in preventing ulcers and amputations in the high-risk diabetic population has received limited experimental investigation. A British descriptive study followed diabetic patients with healed foot ulcers for two years and found reulceration occurred in 72% of patients who resume wearing their own footwear compared to 26% of patients who continued wearing "prescribed" footwear. A Swedish cohort study identified individuals with a foot ulcer and reported their 1, 3, and 5 year reulceration rates at 34%, 61%, and 70%, respectively, without further specifying footwear components. In a German diabetic population the reulceration rate was 87% in-patients who abandoned their custom shoes and resumed wearing their own shoes compared to 42% of those who continued to wear their custom shoes. Unfortunately, none of these studies compared the single or combined contribution of therapeutic shoes or insoles on foot ulcer prevention. Nor did these studies address patient adherence to prescribed footwear; thus the actual efficacy of various footwear interventions in foot ulcer prevention in this high-risk population is still to be tested.
Details: Primary Objective: Half of the 7,646 amputations performed in VA in 1996 were in veterans with diabetes. Lower extremity ulcers preceded about 85% of diabetic amputations. Minor trauma, often footwear or repetitive pressure related, initiated the majority of the ulcers. Persons with diabetes have unique footwear needs. In 1997, Gayle E. Reiber MPH, PhD, and Douglas G. Smith, MD of the VA Puget Sound Health Care System initiated a randomized clinical trial (1) to determine the extent to which study shoes and study inserts would reduce the incidence of re-ulceration in diabetic individuals with a prior foot ulcer history, and (2) to estimate costs of ulcer prevention using these strategies. A total of 400 patients from the VA Puget Sound Health Care System (n=189) and a Seattle-area Health Maintenance Organization, Group Health Cooperative (n=211), have now been randomized to one of three study arms: Arm 1 (n=120) study shoes and customized cork inserts; Arm 2 (n=119) study shoes and generic polyurethane inserts; and Arm 3 (n=161) controls who are wearing their own footwear. Patients in Arms 1 and 2 received formal, leisure and athletic shoes built to study specifications by Cole-Haan for men and by Lowell Shoe for women. Patients will be followed for two years to determine the incidence and cost of foot re-ulceration. Study Abstract: A Seattle VA study indicated lower extremity ulcers preceded 84% of diabetic amputations. Nearly half of the events that ban the causal chain leading to ulcers and amputation were initiated by ill-fitting footwear. Other investigators report similar findings for injurious footwear in their diabetic patient populations. Yet, the efficacy of footwear in preventing ulcers and amputations in the high-risk diabetic population has received limited experimental investigation. A British descriptive study followed diabetic patients with healed foot ulcers for two years and found reulceration occurred in 72% of patients who resume wearing their own footwear compared to 26% of patients who continued wearing "prescribed" footwear. A Swedish cohort study identified individuals with a foot ulcer and reported their 1, 3, and 5 year reulceration rates at 34%, 61%, and 70%, respectively, without further specifying footwear components. In a German diabetic population the reulceration rate was 87% in-patients who abandoned their custom shoes and resumed wearing their own shoes compared to 42% of those who continued to wear their custom shoes. Unfortunately, none of these studies compared the single or combined contribution of therapeutic shoes or insoles on foot ulcer prevention. Nor did these studies address patient adherence to prescribed footwear; thus the actual efficacy of various footwear interventions in foot ulcer prevention in this high-risk population is still to be tested.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria:
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: S003;
Study Start Date: January 1997
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032864
Other Lower Extremity Ulcers Studies:
1. Family-Centered Diabetes Project
2. Improving Service Delivery through Access Points
3. Epidemiology of Hearing Loss in Diabetic and Non-Diabetic Veterans
4. Look AHEAD: Action for Health in Diabetes
5. Clinical Trial of Footwear in Patients with Diabetes
Related Studies:
Other Lower extremity ulcers Clinical Trials
Other Clinical Trials
Other Clinical Trials
Clinical Trial of Footwear in Patients with Diabetes
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