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

NCT04040426 | Completed

• 1 other identifier: SOL-TRA-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Theraskin; Skin Graft; DFU; Ulcer

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 (7)

• Percentage area reduction at 4 weeks

  4 weeks

• Percentage area reduction at 6 weeks

  6 weeks

• Percentage are reduction at 12 weeks

  12 weeks

• Percentage of index ulcers healed at 6 weeks

  6 weeks

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

  12 weeks

Study Arms (2)

Human split thickness skin allograft (Theraskin™)

EXPERIMENTAL

Theraskin™ is an all-human split thickness skin allograft with a native extracellular matrix that can be used an adjunct to standard of care, for skin coverage in patients who have suffered from a diabetic foot wound in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing. Theraskin™ is an allograft tissue and will be used in compliance with homologous use by the FDA under section 361 of the PHS Act and 21 CFR Part 1271

Other: Human split thickness skin allograft; Other: Additional Outer Dressing Applicaiton; Other: Offloading

Fibracol wound dressing

ACTIVE COMPARATOR

A commercially available wound dressing to be used per manufacturer's instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing

Other: Additional Outer Dressing Applicaiton; Other: Offloading; Other: Fibracol Wound Dressing

Interventions

Human split thickness skin allograft OTHER

Application of a fenestrated human skin graft

Also known as: Theraskin™

Human split thickness skin allograft (Theraskin™)

Additional Outer Dressing Applicaiton OTHER

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

Also known as: Outer protective dressing

Fibracol wound dressing; Human split thickness skin allograft (Theraskin™)

Offloading OTHER

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

Also known as: Pressure Relief

Fibracol wound dressing; Human split thickness skin allograft (Theraskin™)

Fibracol Wound Dressing OTHER

Application of Collagen Alginate Dressing

Also known as: calcuim 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 DFU, Wagner Grade 1 (see Appendix A for definitions), extending at least through the dermis provided it is below the medial aspect of the malleolus.
• The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade 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 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
• Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
• Adequate circulation to the affected foot 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 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable.
• The target ulcer has been offloaded for at least 14 days prior to randomization.
• 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

You may not qualify if:

• Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
• 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 with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
• Subjects taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding 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.
• 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.
• Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
• Subject is pregnant or breast-feeding.
• Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days of randomization.
• Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of randomization.
• Index ulcer has reduced in area by 20% or more after 14 days of SOC from SV1 to the TV1/randomization visit.

Sponsors & Collaborators

• Professional Education and Research Institute: lead
• Solsys Medical LLC: collaborator

Study Sites (5)

Center for Clinical Research

San Francisco, California, 94115, United States

Location

Gateway Clinical Trials LLC

O'Fallon, Illinois, 62269, United States

Location

Lower Extremity Institute of Research and Therapy

Youngstown, Ohio, 44512, United States

Location

Martinsville Research Institute

Martinsville, Virginia, 23116, United States

Location

Foot and Ankle Associates of Southwest VA

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Galiano, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• David Armstrong, DPM, MD, PhD

  USC Keck School of Medicine - Salsa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Human Split Thickness Skin Graft Allograft (Theraskin™) in the Treatment of Diabetic Foot Ulcers

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: August 6, 2019
• Primary Completion: September 14, 2021
• Study Completion: October 1, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)