BR-AC for Venous Leg Ulcers

Recruiting at 19 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

Trial Summary

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).

Is BR-AC safe for treating venous leg ulcers?

The safety of AQUACEL™ Ag+ dressing, a similar treatment for venous leg ulcers, was evaluated and found to have an acceptable safety profile, with only one patient discontinuing due to a non-treatment-related issue. This suggests that similar treatments like BR-AC may also be generally safe for use in humans. ^{1 2 3 4 5}

What is the purpose of this trial?

This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VLU will result in a higher proportion 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.

Research Team

Bert Slade, MD

Principal Investigator

Independent

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

External validity of randomized controlled trials of interventions in venous leg ulceration: A systematic review. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Safety and performance evaluation of a next-generation antimicrobial dressing in patients with chronic venous leg ulcers. [2021]

3. England 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). [2014]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Management of chronic wounds with an innovative absorbent wound dressing. [2012]