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

NCT03935386 | Unknown DMC

• 1 other identifier: Soluble Inova
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Rate of wound healing, percentage of wounds that close, and change in wound size in subjects with venous leg ulcers treated with compression therapy with or without a cryopreserved skin allograft (TheraSkin)

  Monitor changes in wound healing rate, percentage of wounds that close, and changes in wound size associated with two cohorts (multi-layered compression therapy vs. multi-layered compression therapy used in conjunction with a cryopreserved skin allograft.

  Enrollment and data analysis is anticipated to require approximately 3 years.

• Determine the number and severity of adverse events associated with the two treatment cohorts -- standardized multi-layered compression therapy and the same therapy with a cryopreserved skin allograft added.

  Measure the frequency and severity of adverse events associated with each treatment cohort.

  Enrollment and data analysis is anticipated to require approximately 3 years.

Study Arms (2)

Standard Compression

ACTIVE COMPARATOR

Standard multi-layer compression dressing with no graft or biologic material added

Procedure: Standard Multi-layered Compression dressing

Standard Compression with application of human allograft

ACTIVE COMPARATOR

standard compression with application of a cryopreserved skin allograft (TheraSkin)

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

Interventions

Standard Multi-layered Compression dressing PROCEDURE

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

Standard Compression

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

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

Standard Compression with application of human allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with venous leg ulcer(s) \>1 month.
• A signed and dated informed consent form.
• Subject is able to comply with instructions and scheduled visits, not confined to bed,.
• Ulcer surface area \>2cm2 but not \>10cm in any dimension. The total not to exceed 18cm2
• ABPI \>.8, Doppler ultrasound (biphasic or triphasic waveforms) consistent with adequate blood flow to the affected extremity, as determined by the Investigator.
• There is a minimum 2 cm margin between the qualifying study ulcer and any other ulcers on the specified leg, post-debridement) Note: If the subject has more than one qualifying VLU, the ulcer designated as the study ulcer will be at the discretion of the Investigator..
• Casual smoker not exceeding one pack per week -

You may not qualify if:

• Patients with ABPI \<0.7.
• Clinical signs of infection requiring treatment. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after resolution of the infection).
• Taking systemic antibiotics, steroids or immunosuppressive drugs.
• History of poor compliance.
• Bedridden.
• Arterial or mixed etiology ulcers.
• Severe diabetic peripheral neuropathy.
• DVT in the last month.
• Participation in another clinical investigations in the month prior to recruitment.
• Poorly controlled hypertension.
• Coronary artery disease.
• Malignancy, respiratory or cardiac failure.
• Autoimmune disease.
• Liver (elevated enzymes)or kidney disease (elevated serum creatinine).
• Gangrene of the affected limb.

Sponsors & Collaborators

• Solsys Medical LLC: lead

Study Sites (1)

Inova Fairfax Hospital

Fairfax, Virginia, 22042, United States

Location

Study Officials

• Philip Garrett, DPM

  Inova Hospital Wound Care Center

  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

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: May 2, 2019
• Study Start: November 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)