BR-AC for Venous Leg Ulcers

Recruiting at 23 trial locations

Overseen By Nick McCoy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BioStem Technologies

Must not be taking: Antibiotics, Cytotoxic agents, Corticosteroids, TNFα inhibitors

Disqualifiers: Pregnancy, HIV/AIDS, Cancer, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for venous leg ulcers (VLUs), which are stubborn wounds often found between the knee and ankle. Researchers aim to determine if adding BioREtain® Amnion Chorion (BR-AC) to standard care helps these wounds heal completely within 12 weeks. If standard care proves insufficient, participants may have the opportunity to try BR-AC afterward to assess its effectiveness. Individuals with a non-healing venous leg ulcer that hasn't been infected and meets specific size and blood flow criteria might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

Do I need to stop taking my current medications to join the trial?

The trial requires you to stop taking certain medications, including systemic antibiotics, cytotoxic agents, chronic oral corticosteroids, and TNFα inhibitors other than Trental® (pentoxifylline).

What prior data suggests that BR-AC is safe for treating venous leg ulcers?

Research has shown that BR-AC, the treatment used in this trial, is generally well-tolerated. In one study, only one patient discontinued use due to a minor issue, suggesting that the treatment does not cause major side effects for most people with venous leg ulcers. Although this treatment is still under investigation, early evidence indicates it is safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

BR-AC is unique because it combines a novel material with standard wound care practices to enhance healing in venous leg ulcers. Unlike traditional treatments that rely solely on debridement, cleansing, and compression, BR-AC is applied directly to the wound, potentially offering a more targeted healing process. Researchers are excited about BR-AC because it may improve wound healing outcomes by maintaining an optimal environment for healing and possibly accelerating recovery time compared to current options.

What evidence suggests that BR-AC might be an effective treatment for venous leg ulcers?

Research has shown that the human placental allograft BioREtain® Amnion Chorion (BR-AC) may help treat venous leg ulcers (VLUs). In this trial, some participants will receive BR-AC along with standard care. Early results suggest that this combination can improve healing compared to standard care alone. Studies on similar treatments have demonstrated that many ulcers heal completely within a certain time frame. While specific data on BR-AC is still being collected, it uses natural materials to aid wound healing. This method has succeeded in similar treatments, offering hope for those with VLUs that are difficult to heal. ^{3 6 7 8 9}

Who Is on the Research Team?

Bert Slade, MD

Principal Investigator

Independent

Are You a Good Fit for This Trial?

This trial is for individuals with non-healing, non-infected venous leg ulcers that have good blood flow but poor vein function. Participants must not have achieved healing with standard care and should be willing to try a new treatment involving human placental allograft.

Inclusion Criteria

My ulcer has been present for 4 weeks to 12 months.

Venous insufficiency confirmed by duplex Doppler ultrasound examining valvular or venous incompetence

Arterial supply adequacy confirmed by specific criteria

Exclusion Criteria

Hemoglobin A1c (HbA1c) level is > 12% (108 mmol/mol)

I am currently taking specific medications.

I have not had cancer, except for non-melanoma skin cancer, in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in

Subjects undergo a run-in period to assess wound area reduction under standard care

2 weeks

1 visit (in-person)

Treatment

Participants receive either standard care or BR-AC plus standard care for 12 weeks

12 weeks

Weekly visits (in-person)

Crossover Treatment

Subjects who did not achieve complete healing under standard care crossover to receive BR-AC for an additional 12 weeks

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for the longevity and durability of wound closure

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BR-AC

Trial Overview

The study tests if adding BR-AC (AmnioWrap2®) to standard ulcer care results in better healing within 12 weeks compared to just the usual treatment. Those who don't heal in this time on standard care can switch to receive BR-AC for another 12 weeks.

How Is the Trial Designed?

Group I: BR-AC plus Standard Care Experimental Treatment 1 Intervention

All subjects in the treatment group will receive sponsor-approved standard of care. Standard of care is defined as: * Sharp debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and * The UrgoK2™ dual compression system providing around 40 mmHg. Using an appropriate size to cover the entire wound area, BR-AC 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.

Group II: Standard Care Active Control 1 Intervention

All subjects in the control group will receive sponsor-approved standard of care. Standard of care is defined as: * Sharp debridement, * Wound cleansing with a neutral, non-irritating and non-toxic solution, * Non-adherent wound contact layer followed by an alginate or foam pad to maintain a moist, warm wound bed, and * The UrgoK2™ dual compression system providing around 40 mmHg.

Who Is Running the Clinical Trial?

BioStem Technologies

Lead Sponsor

Trials

4

Recruited

280+

Published Research Related to This Trial

AQUACEL™ Ag+ dressing demonstrated an acceptable safety profile in treating chronic venous leg ulcers, with only one patient discontinuing due to a non-treatment-related adverse event during the 8-week study involving 42 patients.

After 8 weeks of treatment, 76.2% of patients showed improvement in their ulcers, with a significant average reduction in ulcer size of 54.5%, indicating its efficacy in managing wounds potentially affected by biofilm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and performance evaluation of a next-generation antimicrobial dressing in patients with chronic venous leg ulcers. Harding, KG., Szczepkowski, M., Mikosiński, J., et al.[2021]

The study compared the effectiveness of two types of dressings, Comfeel Extra Absorbing Dressing and Kaltostat Dressing, specifically for treating exudating leg ulcers.

Results from this preliminary study could provide insights into which dressing may be more effective in managing wound exudate and promoting healing, although specific data on outcomes and participant numbers were not provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two dressings in the treatment of heavily exuding leg ulcers. Rainey, J.[2019]

In a pilot study involving 50 patients with venous leg ulcers and pressure ulcers, the innovative absorbent dressing UrgoClean significantly reduced wound surface area by an average of 23.7% for venous leg ulcers and 29.2% for pressure ulcers over a 6-week period, with full healing achieved in 6 patients.

The dressing was well-tolerated and accepted by both patients and nursing staff, showing excellent conformability and ease of use, with minimal local adverse events reported, indicating it is a promising option for managing sloughy wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chronic wounds with an innovative absorbent wound dressing. Meaume, S., Perez, J., Rethore, V., et al.[2012]

A systematic review of 144 randomized controlled trials on treatments for venous leg ulcers revealed inadequate reporting of external validity data, which is crucial for understanding how findings apply to broader patient populations.

Only 32% of studies reported eligibility screening numbers, and there was significant variability in the ankle-brachial pressure index cutoff for patient inclusion, complicating the generalizability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External validity of randomized controlled trials of interventions in venous leg ulceration: A systematic review. Gethin, G., Ivory, JD., Connell, L., et al.[2020]

In a clinical trial involving 159 patients with venous leg ulcers, the new UrgoClean dressing demonstrated similar overall efficacy and safety compared to the standard Aquacel dressing after 6 weeks of treatment.

UrgoClean showed significantly better autolytic properties, with a greater reduction in sloughy tissue (-65.3% vs -42.6%) and a higher percentage of debrided wounds (52.5% vs 35.1%), indicating it may be a more effective option for managing sloughy venous leg ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of two fibrous wound dressings for the management of leg ulcers: results of a European randomised controlled trial (EARTH RCT). Meaume, S., Dissemond, J., Addala, A., et al.[2014]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12188020/

A systematic review and meta-analysis assessing the ...

There were a total of 1,025 participants, with 515 having received PTX. In those receiving 1200 mg PTX, venous leg ulcers healed in 62% (315 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06811909

NCT06811909 | Non-healing Venous Leg Ulcers Treated ...

This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BR-AC plus standard of care versus standard of care ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213333X23003256

Review article Prognostic models for clinical outcomes in ...

The purpose of this review was to identify prognostic models for clinical application in patients with venous leg ulcers (VLUs).

4.

ir.biostemtechnologies.com

ir.biostemtechnologies.com/biostem-receives-institutional-review-board-irb-approval-to-advance-clinical-trial-demonstrating-the-therapeutic-benefits-of-bioretain-technology-in-treating-venous-leg-ulcers/

BioStem Receives Institutional Review Board (IRB) ...

This study aims to assess the efficacy of BR-AC compared to standard of care in patients with non-healing VLUs, providing critical data to support continued ...

5.

jvascsurg.org

jvascsurg.org/article/S0741-5214(06)01006-8/pdf

Chronic venous leg ulcers benefit from surgery

Results: Initially, ulcer healing occurred in 87% of the cases (151 legs). A total of 13% (22 legs) of the venous ulcers never healed, and recurrent venous ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06811909?term=AC%2017&viewType=Table&rank=1

Non-healing Venous Leg Ulcers Treated With Standard ...

This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BR-AC plus standard of care versus standard of care ...

7.

withpower.com

withpower.com/trial/br-ac-for-venous-leg-ulcers-0afbf

BR-AC for Venous Leg Ulcers

AQUACEL™ Ag+ dressing demonstrated an acceptable safety profile in treating chronic venous leg ulcers, with only one patient discontinuing due to a non- ...

8.

ctv.veeva.com

ctv.veeva.com/study/non-healing-venous-leg-ulcers-treated-with-standard-care-with-or-without-br-ac

Non-healing Venous Leg Ulcers Treated With Standard Care ...

This trial is a multicenter, randomized, controlled study designed to evaluate the safety and efficacy of BR-AC plus standard of care versus ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8615583/

Venous Leg Ulcers: Advanced Therapies and New ...

The results of clinical trials on EMT usage for the treatment of venous leg ulcers have inconsistent results. Some of them confirm the ...