SkinTE® in the Treatment of Venous Leg Wounds

N/A

Waitlist Available

Led By David Armstrong, DPM, MD, PhD

Research Sponsored by PolarityTE

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 study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on a commercially available human autologous homologous skin construct with SOC dressing compared to SOC dressings alone in the treatment of Venous Leg Wounds

Eligible Conditions

Venous Leg Ulcer
Venous Ulcers
Post-Thrombotic Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Improvement in quality of life using Wound Quality of Life Score

Percentage are reduction at 12 weeks

+3 more

Other study objectives

Visible Graft Take at each visit

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 Autologous Homologous Skin Construct (SkinTE)Experimental Treatment2 Interventions

SkinTE, is an autologous, homologous, FDA-registered, cutaneous human cellular and tissue-based product (HCT/P) that can be used an adjunct to standard of care, for skin coverage in patients who have suffered from a venous leg wound in conjunction with standard wound care and Additional (outer) Dressing Application with moisture retention dressing and compression

Group II: Fibracol Wound DressingActive Control2 Interventions

A commercially available wound dressing to be used per manufacturer's instructions for use on venous leg wounds in conjunction with standard wound care and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing and compression

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