Non-infected Diabetic Foot UlcerNCT06565156
Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
A study testing BR-AM in people with Non-infected Diabetic Foot Ulcer and Diabetic Foot, run by BioStem Technologies at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-infected Diabetic Foot Ulcer, Diabetic Foot, Diabetic Wound
- What is being tested?
- BR-AM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 17 sitesUnited States
- Study dates
- 28 Oct 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
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- 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.
Who cannot join
- 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.
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- 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 following additional exclusion criteria should be reviewed for all subjects at the end of the screening run-in period prior to randomization for eligibility determination:
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Site 18
Boston, Massachusetts, 02118
Site 29
Brownsville, Texas, 78520
Site 21
Burleson, Texas, 76028
Site 15
Chapel Hill, North Carolina, 27599
Site 27
Coral Gables, Florida, 33134
Site 20
Deerfield Beach, Florida, 33442
Site 28
DeLand, Florida, 32720
Site 26
Detroit, Michigan, 48201
Site 17
Guntersville, Alabama, 35976
Site 16
Lake Success, New York, 11042
Site 22
Mesa, Arizona, 85206
Site 19
Palmdale, California, 93551
Site 24
San Antonio, Texas, 78229
Site 02
San Francisco, California, 94115
Site 23
Springfield, Illinois, 62704
Site 25
Tucson, Arizona, 85723
Site 01
Vista, California, 92081
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
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.
Read the detailed description
This study examines a patient population with a diabetic foot ulcer (DFU) having adequate perfusion without clinical signs and symptoms of infection. Historical data has demonstrated that around 30% of DFUs heal within 12 weeks using standard care alone. However, roughly half of patients suffering from DFUs require additional measures, including advanced therapy. It is hypothesized that weekly applications of the human placental allograft BR-AM applied to a nonhealing DFU will result in a higher rate of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone.
This study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing.
A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow up period will consist of a four-week follow up with two visits at each two-week interval.
- Conditions
- Non-infected Diabetic Foot Ulcer, Diabetic Foot, Diabetic Wound, Diabetic Foot Ulcer, Non-ischemic Diabetic Foot Ulcer
- Being tested
- BR-AM, Standard Care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR-AMOther
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.
Standard CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization.
Measured: at 12 weeks
To compare differences between treatment groups in percent change in wound area (cm2).
Percent change from baseline in wound surface area (cm2) at 12-weeks post-randomization.
Measured: at 12 weeks
To compare differences between treatment groups in percent change in wound volume (cm3).
Percent change from baseline in wound volume (cm3) at 12-weeks post-randomization.
Measured: at 12 weeks
To determine the total number of applications of BR-AM needed to achieve complete wound closure.
Total number of applications of BR-AM to achieve complete wound closure over 12-weeks post-randomization.
Measured: 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.
Time in days from Visit 18 to initial observation of wound closure (defined as 100% reepithelialization of the wound without drainage) over an additional 12 weeks (Visits 19-30), where healing has been confirmed at two visits two weeks apart.
Measured: over an additional 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start28 Oct 2024
- Primary completion14 Nov 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infected Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioStem Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bert Slade, MD, Study director, Independent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565156
- Sponsor's protocol ID
- BR-AM-DFU-101
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled Trial of Non-healing Diabetic Foot Ulcers Treated With Standard Care With or Without BR-AM
- ClinicalTrials.gov ID
- NCT06565156
- Acronym / sponsor ID
- BR-AM-DFU-101
- Conditions
- Non-infected Diabetic Foot Ulcer, Diabetic Foot, Diabetic Wound, Diabetic Foot Ulcer, Non-ischemic Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- BioStem TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study examines a patient population with a diabetic foot ulcer (DFU) having adequate perfusion without clinical signs and symptoms of infection. Historical data has demonstrated that around 30% of DFUs heal within 12 weeks using standard care alone. However, roughly half of patients suffering from DFUs require additional measures, including advanced therapy. It is hypothesized that weekly applications of the human placental allograft BR-AM applied to a nonhealing DFU will result in a higher rate of wounds showing complete healing within 12 weeks of initiating therapy, compared to standard care alone.
This study has a crossover period, where subjects on standard care alone who do not achieve complete healing within 12 weeks of initiating therapy will be allowed to crossover to receive BR-AC over 12 additional weeks, to evaluate if their wound can achieve complete healing.
A follow-up phase will commence for all subjects that achieve complete wound closure, which is designed to measure longevity and durability of the closed wound. This follow up period will consist of a four-week follow up with two visits at each two-week interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BR-AM plus Standard Care | Experimental | Other: BR-AMAll 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. |
| Standard Care | Active comparator | Other: Standard CareAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR-AMBR-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. | Other | BR-AM plus Standard Care |
| Standard CareStandard 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 |
Primary outcome
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.
Time frame: over the 12-week treatment period
Percentage of subjects with complete wound closure over the 12-week treatment period, defined as 100% reepithelialization
5 secondary outcomes
To compare differences between treatment groups in proportions of wounds with complete wound closure, based on time in days to closure.
Time frame: at 12 weeks
To compare differences between treatment groups in percent change in wound area (cm2).
Time frame: at 12 weeks
To compare differences between treatment groups in percent change in wound volume (cm3).
Time frame: at 12 weeks
To determine the total number of applications of BR-AM needed to achieve complete wound closure.
Time frame: 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.
Time frame: over an additional 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bert Slade, MD study director
Independent
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BR-AM in people with Non-infected Diabetic Foot Ulcer and Diabetic Foot, run by BioStem Technologies at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: over the 12-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.