SkinTE™ in the Treatment of Diabetic Foot Wounds

NCT03881254 | Completed

• 1 other identifier: STE-DFU-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 Diabetic Foot Wounds.

Conditions

Diabetic Foot; Diabetic Foot Ulcer; Ulcer Foot

Keywords

DFU; Ulcer; Skin TE

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 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 diabetic foot wound in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing

Other: Human Autologous Homologous Skin Construct; 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 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 Applicaiton OTHER

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

Also known as: Outer protective dressing

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

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 Autologous Homologous Skin Construct (SkinTE™)

Fibracol Wound Dressing OTHER

Application of Collagen Alginate Dressing

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 1 (see Appendix B 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 Toe Brachial Index (TBI) 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.
• 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.

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 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.
• 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, cellulitis, or "active" Charcot's arthropathy of the affected foot near the site of the wound or on the same limb as the index ulcer as verified by X-ray, MRI, or bone biopsy within 30 days prior to randomization if any of the aforementioned conditions are expected. (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 30 days of randomization.
• Subjects with end stage renal disease as evidenced by a serum creatinine of greater than 3.0 mg/dl within 120 days of randomization.
• Target wound has presence of local active soft tissue infection or Gangrene involving the treatment site.
• Index ulcer has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/randomization visit.
• In the opinion of the Investigator, evidence of unstable human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening.

Sponsors & Collaborators

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

Study Sites (1)

Martinsville Research Institute

Martinsville, Virginia, 23116, United States

Location

Related Publications (1)

• Armstrong DG, Orgill DP, Galiano R, Glat PM, Carter M, Zelen CM, Li WW. Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers. Int Wound J. 2020 Oct;17(5):1366-1375. doi: 10.1111/iwj.13404. Epub 2020 May 26.

  PMID: 32453512 BACKGROUND

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

• David Armstrong, DPM, MD, PhD

  USC / Salsa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• 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 Diabetic Foot Ulcers

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 19, 2019
• Study Start: April 2, 2019
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)