SkinTE® in the Treatment of Venous Leg Wounds

NCT03881267 | Completed

• 1 other identifier: STE-VLU-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Venous Leg Ulcer; Venous Stasis; Venous Stasis Ulcer

Keywords

VLU; Ulcer; SkinTE

Outcome Measures

Primary Outcomes (1)

• Percentage of index ulcers healed at 12 weeks

  examine percent of ulcers healed at week twelve

  12 weeks

Secondary Outcomes (6)

• Percentage area reduction at 4 weeks

  4 weeks

• Percentage area reduction at 6 weeks

  6 weeks

• Percentage area reduction at 8 weeks

  8 weeks

• Percentage are reduction at 12 weeks

  12 weeks

• Improvement in quality of life using Wound Quality of Life Score

  12 weeks

Other Outcomes (1)

• Visible Graft Take at each visit

  12 weeks

Study Arms (2)

Human Autologous Homologous Skin Construct (SkinTE)

EXPERIMENTAL

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

Other: Human Autologous Homologous Skin Construct; Other: Additional Outer Dressing Application

Fibracol Wound Dressing

ACTIVE COMPARATOR

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

Other: Additional Outer Dressing Application; Other: Fibracol Wound Dressing

Interventions

Human Autologous Homologous Skin Construct OTHER

Application of a autologous human derived skin polar units

Also known as: SkinTE

Human Autologous Homologous Skin Construct (SkinTE)

Additional Outer Dressing Application OTHER

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

Also known as: •Outer protective and compressive dressing

Fibracol Wound Dressing; Human Autologous Homologous Skin Construct (SkinTE)

Fibracol Wound Dressing OTHER

Application of Collagen Alginate Dressing

Also known as: Collegen Alginate

Fibracol Wound Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old.
• Presence of a VLU on the leg, below the knee but above the aspect of the medial malleolus, extending at least through the dermis or subcutaneous tissue but not involving tendon, muscle, or bone.
• The index ulcer will be the largest ulcer if two or more VLUs are present and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
• Index ulcer (i.e. current episode of ulceration) has been present for greater than four weeks prior to the initial screening visit, as of the date subject consents for study.
• Index ulcer is a minimum of 2.0 cm2 and a maximum of 20 cm2 at first screening visit (SV1) and first treatment visit (TV1).
• Adequate circulation to the affected extremity as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between ≥ 0.7 and ≤ 1.2 or Arterial Doppler with a minimum of biphasic flow within 3 months of SV1, using the affected study extremity.
• The index ulcer has been treated with high compression for at least 14 days prior to randomization (30-40 mm Hg).
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits and follow-up regimen.
• Subject has read and signed the IRB/IEC approved Informed Consent Form before screening procedures have been completed.
• The index ulcer has a clean granular base, is free of necrotic debris, and appears to be healthy vascularized tissue at time of placement of treatment product.
• Subject is deemed healthy and stable for treatment based per PI discretion.

You may not qualify if:

• Subjects with a BMI ≥45
• Index ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency.
• Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
• Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit (SV1).
• History of radiation at the ulcer site (regardless of time since last radiation treatment).
• Index ulcer has been previously treated or will need to be treated with any prohibited therapies, such as chlorhexidine or collagenase. (See Section 7.3 of this protocol for a list of prohibited medications and therapies).
• Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \> 10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the study.
• Study ulcer requiring negative pressure wound therapy during the course of the trial.
• Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
• Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
• Subject is pregnant or breast-feeding.
• Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization.
• Subjects with end stage renal disease as evidenced by a creatinine greater than 3.0mg/dl within 120 days of randomization.
• Target wound has presence of local active soft tissue infection involving the treatment site.

Sponsors & Collaborators

• PolarityTE: lead
• Professional Education and Research Institute: collaborator

Study Sites (2)

Martinsville Research Institute

Martinsville, Virginia, 23116, United States

Location

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Armstrong, DPM, MD, PhD

  USC/ Salsa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Human Homologous Autologous Skin Construct (SkinTE™) in the Treatment of Venous Leg Ulcers

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 19, 2019
• Study Start: March 29, 2019
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)