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Standard Compression Therapy With/Without Application of Skin Allograft (Theraskin) for Venous Leg Ulcer Treatment

NCT03935386 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-05-02

No results posted yet for this study

Summary

This study will compare the efficacy of using standard compression therapy for treatment of chronic venous leg ulcers vs. the standard compression therapy with the additional use of the application of a human allograft (Theraskin)

Conditions

  • Chronic Venous Hypertension With Ulcer

Interventions

PROCEDURE

Standard Multi-layered Compression dressing

Compression therapy with a multi-layered compression dressing for the treatment of venous leg ulceration

PROCEDURE

Standard Multi-layered Compression dressing with a cryopreserved skin allograft (TheraSkin)

Application of a cryopreserved skin allograft (TheraSkin) beneath compression therapy with a multi-layered compression dressing.

Sponsors & Collaborators

  • Solsys Medical LLC

    lead INDUSTRY

Principal Investigators

  • Philip Garrett, DPM · Inova Hospital Wound Care Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2020-12-31
Completion
2020-12-31

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 NCT03935386 on ClinicalTrials.gov