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Efficacy and Safety Study of Dermal-Living Skin Replacement to Treat Diabetic Foot Ulcers

NCT00368693 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-04-07

No results posted yet for this study

Summary

The purpose of this study is to test the efficacy and side effects, if any, of Dermal - LSR combined with standard treatment. We hypothesize the treatment will provide beneficial results for diabetic patients suffering foot ulcers.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Dermal - Living Skin Replacement (Dermal-LSR)

The only experimental procedure is the application of the study device, Dermal - Living Skin Replacement (Dermal - LSR), to the foot ulcer. All others are regular or standard procedures. Dermal - LSR is a gel containing living human skin cells. This gel is applied directly to ulcers to help repair the skin. The cells used in this study device have come from one foreskin (skin covering the tip of the penis) taken from a baby boy shortly after his birth for reasons unrelated to this study. All cells that will be used have been tested to be healthy and safe. The amount of the study device you will receive depends on the size of your ulcer at each treatment visit. You will receive less than a 1/4 teaspoon of Dermal - LSR for about every dime-size area of your ulcer as measured and calculated by the research investigator.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Roslyn R Isseroff, M.D. · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00368693 on ClinicalTrials.gov