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Bioactive Split Thickness Skin Allograft Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

NCT04040426 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-01-28

No results posted yet for this study

Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data as well as assess performance and safety of a commercially available human split thickness skin allograft with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds.

Conditions

  • Diabetic Foot
  • Ulcer Foot

Interventions

OTHER

Human split thickness skin allograft

Application of a fenestrated human skin graft

OTHER

Additional Outer Dressing Applicaiton

Application of Moisture retentive dressing, and a multi-layer compression dressing

OTHER

Offloading

Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot

OTHER

Fibracol Wound Dressing

Application of Collagen Alginate Dressing

Sponsors & Collaborators

  • Solsys Medical LLC

    collaborator INDUSTRY

  • Professional Education and Research Institute

    lead OTHER

Principal Investigators

  • Robert Galiano, MD · Northwestern University

  • David Armstrong, DPM, MD, PhD · USC Keck School of Medicine - Salsa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-06
Primary Completion
2021-09-14
Completion
2021-10-01

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 NCT04040426 on ClinicalTrials.gov