ACTIVE_NOT_RECRUITING

SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)

Conditions

Diabetic Foot diabetic foot ulcer regenerative medicine SkinTE skin regeneration chronic wounds Wagner 1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.

Official Title

Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers. Closure Obtained With Vascularized Epithelial Regeneration for DFUs With SkinTE® II (COVER DFUS II)

Quick Facts

Study Start:2024-02-22

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06140303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* At least 18 years of age. * Documented history of Type I or Type II Diabetes Mellitus requiring oral and/or insulin replacement therapy. * Presence of a DFU Wagner 1 grade wound on any aspect of the foot, provided that if the malleolus is involved, not more than 50% of the wound is above the mid-point of the medial malleolus. \[NOTE: DFU must maintain Wagner 1 Grade for the duration of study run-in period - i.e., screening visit 1 (SV1) to randomization visit 1 (RV1).\] * If other wounds are present on the same foot, they must be more than 2 cm distant from the index ulcer. \[NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study.\] * Index ulcer (i.e., current episode of ulceration) has been present for ≥ four weeks (≥28 days) prior to the initial screening visit (SV1). * Index ulcer (post-debridement) is a minimum of 1.0 cm2 and a maximum of 15 cm2 at first screening visit (SV1) and first randomization visit (RV1). * 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) of ≥ 0.7 and ≤ 1.2, or Arterial Doppler with a minimum of biphasic flow or Toe Brachial Index (TBI) ≥ 0.75, using the affected study extremity within 30 days of screening visit (SV1). * Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines PEDIS Grade level 1. * The index ulcer has been offloaded with protocol defined offloading device throughout study run-in period for at least 14 days prior to randomization (Run-in period defined as Screening through RV1/Randomization). * Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile). * Subject understands and is willing to participate in the clinical study and can comply with study visits and the follow-up regimen. * Females of childbearing potential must agree to use effective methods of c contraception (birth control pills, barriers, or abstinence) (Screening through End of Study (EOS) and undergo pregnancy tests. * Properly obtained written informed consent. * Subject must have stable living environment in order to manage offloading and wound care management. * The index ulcer has a clean base, free of necrotic debris, and infection at time of placement of treatment product.	* Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1). * Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of screening visit (SV1). * Index ulcer in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer. * Subjects with history of radiation on the same limb as the index ulcer (regardless of time since last radiation treatment). * Subjects with exposed internal fixation on the same limb as the index ulcer \[NOTE: External fixation is allowed if deemed stable by principal investigator.\] * Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first screening visit (SV1). \[NOTE: NPWT is allowed up to the day of screening (SV1), if in the opinion of the Principal Investigator NPWT may be discontinued.\] * Index ulcer treated within the last 30 days prior to screening with a prohibited treatment as defined in full protocol. * Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \> 10mg prednisone (or equivalent) daily dose), cytotoxic chemotherapy, or application of topical steroids to the index ulcer surface within 30 days prior to first screening visit (SV1), or who receive such medications during the run-in 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 to medical treatment. * In the opinion of the Investigator, the subject is non-compliant with offloading or index ulcer dressing during the run-in period. * Active Charcot's arthropathy of the index ulcer limb as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1). * Subjects with chronic osteomyelitis and/or cellulitis on the same limb as the index ulcer as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1). * Subject is pregnant or breast-feeding. * Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days prior to randomization (RV1). * Subjects with end stage renal disease requiring treatment with dialysis and/or evident by an eGFR \<30 mL/min/1.73m2 within 120 days of randomization (RV1). \[NOTE: Subjects with two documented eGFR values within 120 days, the most recent value may be used if the eGFR ≥30 mL/min/1.73m2 and is, in the opinion of the principal investigator, stable and the subject will not require treatment with dialysis for the duration of study participation.\] * Index ulcer has reduced or increased in area by 30% or more after 14 days of SOC from SV1 to the RV1/randomization visit. * Evidence of unstable human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C in the opinion of the investigator at screening (SV1). * Documented history of New York Heart Association Class III or IV congestive heart failure or unstable cardiovascular disease requiring intervention within 60 days prior to screening (SV1). * Requiring surgical intervention (excluding debridement) at the time of consenting and/or increased probability of requiring surgical intervention during study participation. \[NOTE: non-invasive surgical intervention is allowed if, per the Principal Investigator, treatment will not affect subject's ability to participate in clinical trial.\] * Any clinically significant finding, in the judgment of the investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.

Inclusion Criteria

Exclusion Criteria

* At least 18 years of age.
* Documented history of Type I or Type II Diabetes Mellitus requiring oral and/or insulin replacement therapy.
* Presence of a DFU Wagner 1 grade wound on any aspect of the foot, provided that if the malleolus is involved, not more than 50% of the wound is above the mid-point of the medial malleolus. \[NOTE: DFU must maintain Wagner 1 Grade for the duration of study run-in period - i.e., screening visit 1 (SV1) to randomization visit 1 (RV1).\]
* If other wounds are present on the same foot, they must be more than 2 cm distant from the index ulcer. \[NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study.\]
* Index ulcer (i.e., current episode of ulceration) has been present for ≥ four weeks (≥28 days) prior to the initial screening visit (SV1).
* Index ulcer (post-debridement) is a minimum of 1.0 cm2 and a maximum of 15 cm2 at first screening visit (SV1) and first randomization visit (RV1).
* 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) of ≥ 0.7 and ≤ 1.2, or Arterial Doppler with a minimum of biphasic flow or Toe Brachial Index (TBI) ≥ 0.75, using the affected study extremity within 30 days of screening visit (SV1).
* Index ulcer and/or index ulcer limb may have had prior infection(s), but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines PEDIS Grade level 1.
* The index ulcer has been offloaded with protocol defined offloading device throughout study run-in period for at least 14 days prior to randomization (Run-in period defined as Screening through RV1/Randomization).
* Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile).
* Subject understands and is willing to participate in the clinical study and can comply with study visits and the follow-up regimen.
* Females of childbearing potential must agree to use effective methods of c contraception (birth control pills, barriers, or abstinence) (Screening through End of Study (EOS) and undergo pregnancy tests.
* Properly obtained written informed consent.
* Subject must have stable living environment in order to manage offloading and wound care management.
* The index ulcer has a clean base, free of necrotic debris, and infection at time of placement of treatment product.

* Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1).
* Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of screening visit (SV1).
* Index ulcer in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
* Subjects with history of radiation on the same limb as the index ulcer (regardless of time since last radiation treatment).
* Subjects with exposed internal fixation on the same limb as the index ulcer \[NOTE: External fixation is allowed if deemed stable by principal investigator.\]
* Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first screening visit (SV1). \[NOTE: NPWT is allowed up to the day of screening (SV1), if in the opinion of the Principal Investigator NPWT may be discontinued.\]
* Index ulcer treated within the last 30 days prior to screening with a prohibited treatment as defined in full protocol.
* Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \> 10mg prednisone (or equivalent) daily dose), cytotoxic chemotherapy, or application of topical steroids to the index ulcer surface within 30 days prior to first screening visit (SV1), or who receive such medications during the run-in 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 to medical treatment.
* In the opinion of the Investigator, the subject is non-compliant with offloading or index ulcer dressing during the run-in period.
* Active Charcot's arthropathy of the index ulcer limb as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1).
* Subjects with chronic osteomyelitis and/or cellulitis on the same limb as the index ulcer as verified by clinical evaluation, and/or imaging (x-ray or MRI) within 30 days prior to randomization (RV1).
* Subject is pregnant or breast-feeding.
* Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days prior to randomization (RV1).
* Subjects with end stage renal disease requiring treatment with dialysis and/or evident by an eGFR \<30 mL/min/1.73m2 within 120 days of randomization (RV1). \[NOTE: Subjects with two documented eGFR values within 120 days, the most recent value may be used if the eGFR ≥30 mL/min/1.73m2 and is, in the opinion of the principal investigator, stable and the subject will not require treatment with dialysis for the duration of study participation.\]
* Index ulcer has reduced or increased in area by 30% or more after 14 days of SOC from SV1 to the RV1/randomization visit.
* Evidence of unstable human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C in the opinion of the investigator at screening (SV1).
* Documented history of New York Heart Association Class III or IV congestive heart failure or unstable cardiovascular disease requiring intervention within 60 days prior to screening (SV1).
* Requiring surgical intervention (excluding debridement) at the time of consenting and/or increased probability of requiring surgical intervention during study participation. \[NOTE: non-invasive surgical intervention is allowed if, per the Principal Investigator, treatment will not affect subject's ability to participate in clinical trial.\]
* Any clinically significant finding, in the judgment of the investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.

Contacts and Locations

Principal Investigator

Nikolai Sopko, MD, PhD

STUDY_DIRECTOR

PolarityBio

Study Locations (Sites)

Titan Clinical Research

Mesa, Arizona, 85202

United States

Center for Clinical Research

Castro Valley, California, 94546

United States

Limb Preservation Platform, Inc.

Fresno, California, 93710

United States

Angel City Research

Los Angeles, California, 90010

United States

Clemente Clinical Research Inc.

Los Angeles, California, 92704

United States

Center for Clinical Research

San Francisco, California, 94115

United States

Clemente Clinical Research Inc.

Santa Ana, California, 92704

United States

ILD Research

Vista, California, 92081

United States

Las Mercedes Medical Research, Inc.

Hialeah, Florida, 33010

United States

Doctors Research Network

Miami, Florida, 33156

United States

DMI Research

Pinellas Park, Florida, 33782

United States

Barry University Clinical Research

Tamarac, Florida, 33321

United States

FASMA - Hagerstown

Hagerstown, Maryland, 21742

United States

Viable Research Management

Henderson, Nevada, 89014

United States

Northwell Health, Inc.

New Hyde Park, New York, 11042

United States

Mount Sinai West Hospital

New York, New York, 10019

United States

LEIRT (Lower Extremity Institute for Research and Therapy)

Boardman, Ohio, 44512

United States

Cutting Edge Research LLC

Circleville, Ohio, 43123

United States

LEIRT (Lower Extremity Institute for Research and Therapy)

East Liverpool, Ohio, 43920

United States

Cutting Edge Research LLC

Grove City, Ohio, 43123

United States

Perfizien Clinical Research LLC.

Houston, Texas, 77055

United States

Baylor Scott & White Health

Plano, Texas, 75093

United States

Foot and Ankle Specialists of the Mid-Atlantic

Salem, Virginia, 24153

United States

Collaborators and Investigators

Sponsor: PolarityTE

Nikolai Sopko, MD, PhD, STUDY_DIRECTOR, PolarityBio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-22

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2024-02-22

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

diabetic foot ulcer
regenerative medicine
SkinTE
skin regeneration
chronic wounds
Wagner 1

Additional Relevant MeSH Terms

Diabetic Foot