SkinTE for Diabetic Foot

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Texas Southwestern Wound Care Clinic, Dallas, TX
Diabetic Foot
SkinTE - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 2 diabetic foot ulcers.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Assessed at 4, 8, 12, 16, and 24 weeks

24 weeks
Incidence of adverse events of the index ulcer
Incidence of index ulcers closed
Incidence of pain, infection, and complications of the harvest site
Time to closure
Wound Quality of Life (w-QoL) Questionnaire
Wound infection
Week 24
Percent area reduction (PAR)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

SkinTE
1 of 1
Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: SkinTE · No Placebo Group · Phase 3

SkinTE
Biological
Experimental Group · 1 Intervention: SkinTE · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at 4, 8, 12, 16, and 24 weeks
Closest Location: University of Texas Southwestern Wound Care Clinic · Dallas, TX
Photo of Dallas  1Photo of Dallas  2Photo of Dallas  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Diabetic Foot
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Presence of a DFU Wagner 2 grade wound on any aspect of the foot, provided it is at or below the aspect of the medial malleolus.
If other wounds are present on the same foot, they must be more than 2 cm distant from the index ulcer.
You have a history of lower limb ischemia, and the limb perfusion pressure is <30 mmHg or the ankle-brachial index is <0.7 or the toe-brachial index is <0.75.
You have had an index ulcer or index ulcer limb for at least 6 months
You are a female of childbearing potential.
You have Type I or Type II Diabetes Mellitus.
You are at least 18 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.