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

NCT06565156 | Active Not Recruiting

• 1 other identifier: BR-AM-DFU-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• To determine whether DFUs treated with standard care plus BR-AM results in a higher probability of achieving complete wound closure compared to standard care alone.

  Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization

  over the 12-week treatment period

Secondary Outcomes (5)

• To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure.

  at 12 weeks

• To compare differences between treatment groups in percent change in wound area (cm2).

  at 12 weeks

• To compare differences between treatment groups in percent change in wound volume (cm3).

  at 12 weeks

• To determine the total number of applications of BR-AM needed to achieve complete wound closure.

  over 12-weeks post-randomization

• To determine whether subjects that crossover and receive standard care plus BR-AM results in a higher probability of achieving complete wound closure over the 12 additional weeks versus standard care alone based on time in days to closure.

  over an additional 12 weeks

Other Outcomes (2)

• Number of participants that acquire clinical signs and symptoms of infections post-randomization

  over 12-weeks post-randomization

• Proportion of subjects experiencing adverse events, by treatment group

  over the 17-week study period

Study Arms (2)

BR-AM plus Standard Care

EXPERIMENTAL

All subjects in the treatment group will receive sponsor-approved standard of care. Standard of care is defined as: * Debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer, a foam pad, alginate or hydrofiber dressing for moderately draining wounds, a secondary retention bandage, and * An off-loading device. Using an appropriate size to cover the entire wound area, BR-AM should be applied directly to the wound surface following sharp debridement. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application.

Other: BR-AM

Standard Care

ACTIVE COMPARATOR

All subjects in the control group will receive sponsor-approved standard of care. Standard of care is defined as: * Debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer, a foam pad, alginate or hydrofiber dressing for moderately draining wounds, a secondary retention bandage, and * An off-loading device.

Other: Standard Care

Interventions

BR-AM OTHER

BR-AM is a single-layer amniotic membrane allograft. BR-AM is manufactured by BioStem Technologies, Inc. and is processed by the bioREtain method which, briefly, includes initial disinfection, processing with isotonic solutions, dehydration at 37-40°C and electron beam sterilization.

BR-AM plus Standard Care

Standard Care OTHER

Standard of care is defined as: * Debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer, a foam pad, alginate or hydrofiber dressing for moderately draining wounds, a secondary retention bandage, and * An off-loading device.

Standard Care

Eligibility Criteria

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

You may qualify if:

• 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.
• a. If more than one ulcer is present the selected target ulcer must be at least 2 cm from the nearest edge of any adjacent ulcers.
• 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:
• Great toe pressure ≥ 40 mm/Hg
• Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20
• TcPO2 ≥ 30 mmHg from the foot
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioStem Technologies: lead

Study Sites (17)

Site 17

Guntersville, Alabama, 35976, United States

Location

Site 22

Mesa, Arizona, 85206, United States

Location

Site 25

Tucson, Arizona, 85723, United States

Location

Site 19

Palmdale, California, 93551, United States

Location

Site 02

San Francisco, California, 94115, United States

Location

Site 01

Vista, California, 92081, United States

Location

Site 27

Coral Gables, Florida, 33134, United States

Location

Site 20

Deerfield Beach, Florida, 33442, United States

Location

Site 28

DeLand, Florida, 32720, United States

Location

Site 23

Springfield, Illinois, 62704, United States

Location

Site 18

Boston, Massachusetts, 02118, United States

Location

Site 26

Detroit, Michigan, 48201, United States

Location

Site 16

Lake Success, New York, 11042, United States

Location

Site 15

Chapel Hill, North Carolina, 27599, United States

Location

Site 29

Brownsville, Texas, 78520, United States

Location

Site 21

Burleson, Texas, 76028, United States

Location

Site 24

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bert Slade, MD

  Independent

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To reduce bias in the determination of closure, an independent blinded reviewer will review the image obtained from the wound measurement device in each case where the Investigator determines the wound has achieved closure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: October 28, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (17)