← Back to Search

Skin Allograft

Human split thickness skin allograft (Theraskin™) for Diabetic Foot

N/A
Waitlist Available
Led By Robert Galiano, MD
Research Sponsored by Professional Education and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare how well a skin allograft heals diabetic foot wounds compared to standard care.

Eligible Conditions
  • Diabetic Foot
  • Venous Leg Ulcer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of index ulcers healed at 12 weeks
Secondary study objectives
Change in pain levels during trial, using the FACES pain scales which measure pain on a range of 0-10, zero being no pain and 10 being the most severe pain
Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10"point
Improvement in quality of life using Wound Quality of Life Score
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Human split thickness skin allograft (Theraskin™)Experimental Treatment3 Interventions
Theraskin™ is an all-human split thickness skin allograft with a native extracellular matrix that can be used an adjunct to standard of care, for skin coverage in patients who have suffered from a diabetic foot wound in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing. Theraskin™ is an allograft tissue and will be used in compliance with homologous use by the FDA under section 361 of the PHS Act and 21 CFR Part 1271
Group II: Fibracol wound dressingActive Control3 Interventions
A commercially available wound dressing to be used per manufacturer's instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing

Find a Location

Who is running the clinical trial?

Solsys Medical LLCIndustry Sponsor
6 Previous Clinical Trials
397 Total Patients Enrolled
2 Trials studying Diabetic Foot
53 Patients Enrolled for Diabetic Foot
Professional Education and Research InstituteLead Sponsor
14 Previous Clinical Trials
1,068 Total Patients Enrolled
13 Trials studying Diabetic Foot
1,039 Patients Enrolled for Diabetic Foot
Robert Galiano, MDPrincipal InvestigatorNorthwestern University
5 Previous Clinical Trials
480 Total Patients Enrolled
2 Trials studying Diabetic Foot
320 Patients Enrolled for Diabetic Foot
~16 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top