ACTIVE_NOT_RECRUITING

Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM

Conditions

Non-infected Diabetic Foot Ulcer Diabetic Foot Diabetic Wound Diabetic Foot Ulcer Non-ischemic Diabetic Foot Ulcer

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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

This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BioREtain® Amniotic Membrane (BR-AM) plus standard of care versus standard of care only in the treatment of diabetic foot ulcers. The trial design will control potential variables that may affect the outcome between the treatment group and the control group by standardizing the requirements for debridement, wound dressings, and offloading. Weekly subject visits will help monitor compliance in wound care and off-loading, as well as to document when wound closure is achieved. The study will also implement the use of an electronic imaging and measurement device using a standardized protocol to ensure the measuring of the wound surface area and volume is accurate, highly reproducible, and minimally variable. There will also be a crossover treatment phase for those patients that were relegated to standard care only. After their 12-week standard of care treatment phase and for only those subjects that did not achieve complete wound closure, will be allowed to crossover for an additional 12 weeks of treatment with the BR-AM product following the protocol and procedures set forth within this document.

Official Title

A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM

Quick Facts

Study Start:2024-10-28

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06565156

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
* Patient has signed the informed consent form. * Male or female patient at least 18 years of age or older, as of the date of the screening visit. * Confirmed diagnosis of Type 1 or Type 2 Diabetes. * Has a DFU that is located below the malleoli at least 1.0 cm2 or up to 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement. * The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule. * The target ulcer is "chronic, hard-to-heal," defined as having a duration of \> 4 weeks but ≤ 52 weeks at the time of the screening visit. * Arterial supply adequacy to the foot with the target ulcer confirmed by any one of the following: 1. Great toe pressure ≥ 40 mm/Hg 2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20 3. TcPO2 ≥ 30 mmHg from the foot 4. Toe Brachial Index or TBI ≥ 0.50 * Willing to follow all instructions given by the Investigator, return for all visits, and adhere to off-loading protocols while on the study.	* Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol). * Chronic oral steroid use of \> 7.5 mg daily within the previous 30 days preceding screening. * Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening. * Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS). * Has malignancy or history of cancer in 5 years preceding the screening visit other than non-melanoma skin cancer. * Pregnant women. * Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control. * Currently on dialysis or planning to start dialysis. * Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening. * Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies within the last 30 days. * Current use of topical anti-microbial or silver-containing products. * Target ulcer is over an active or inactive Charcot deformity. * The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and/or joint capsule. * Gangrene is present on any part of the affected foot. * Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection. * Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer. * The target ulcer has decreased \> 30% in wound area post debridement at baseline following the two-week run-in period. * Use of excluded concomitant medications, therapies, or procedures during the two-week run-in period. * Has clinical signs or symptoms of infection within the target ulcer.

Inclusion Criteria

Exclusion Criteria

* Patient has signed the informed consent form.
* Male or female patient at least 18 years of age or older, as of the date of the screening visit.
* Confirmed diagnosis of Type 1 or Type 2 Diabetes.
* Has a DFU that is located below the malleoli at least 1.0 cm2 or up to 20.0 cm2 when measured by the investigator staff at the screening visit using the eKare device post debridement.
* The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule.
* The target ulcer is "chronic, hard-to-heal," defined as having a duration of \> 4 weeks but ≤ 52 weeks at the time of the screening visit.
* Arterial supply adequacy to the foot with the target ulcer confirmed by any one of the following:
1. Great toe pressure ≥ 40 mm/Hg
2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20
3. TcPO2 ≥ 30 mmHg from the foot
4. Toe Brachial Index or TBI ≥ 0.50
* Willing to follow all instructions given by the Investigator, return for all visits, and adhere to off-loading protocols while on the study.

* Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol).
* Chronic oral steroid use of \> 7.5 mg daily within the previous 30 days preceding screening.
* Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
* Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
* Has malignancy or history of cancer in 5 years preceding the screening visit other than non-melanoma skin cancer.
* Pregnant women.
* Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
* Currently on dialysis or planning to start dialysis.
* Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
* Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies within the last 30 days.
* Current use of topical anti-microbial or silver-containing products.
* Target ulcer is over an active or inactive Charcot deformity.
* The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and/or joint capsule.
* Gangrene is present on any part of the affected foot.
* Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection.
* Any previous use of Vendaje®, Vendaje AC®, AmnioWrap2® applied to the target ulcer.
* The target ulcer has decreased \> 30% in wound area post debridement at baseline following the two-week run-in period.
* Use of excluded concomitant medications, therapies, or procedures during the two-week run-in period.
* Has clinical signs or symptoms of infection within the target ulcer.

Contacts and Locations

Principal Investigator

Bert Slade, MD

STUDY_DIRECTOR

Independent

Study Locations (Sites)

Site 17

Guntersville, Alabama, 35976

United States

Site 22

Mesa, Arizona, 85206

United States

Site 25

Tucson, Arizona, 85723

United States

Site 19

Palmdale, California, 93551

United States

Site 02

San Francisco, California, 94115

United States

Site 01

Vista, California, 92081

United States

Site 27

Coral Gables, Florida, 33134

United States

Site 20

Deerfield Beach, Florida, 33442

United States

Site 28

DeLand, Florida, 32720

United States

Site 23

Springfield, Illinois, 62704

United States

Site 18

Boston, Massachusetts, 02118

United States

Site 26

Detroit, Michigan, 48201

United States

Site 16

Lake Success, New York, 11042

United States

Site 15

Chapel Hill, North Carolina, 27599

United States

Site 29

Brownsville, Texas, 78520

United States

Site 21

Burleson, Texas, 76028

United States

Site 24

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: BioStem Technologies

Bert Slade, MD, STUDY_DIRECTOR, Independent

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 Date2024-10-28

Study Completion Date2026-06

Study Record Updates

Study Start Date2024-10-28

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Non-infected Diabetic Foot Ulcer
Diabetic Foot
Diabetic Wound
Diabetic Foot Ulcer
Non-ischemic Diabetic Foot Ulcer