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BR-AC + Standard Care for Diabetic Foot Ulcers

N/A

Recruiting

Research Sponsored by BioStem Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Confirmed diagnosis of Type 1 or Type 2 Diabetes

Must not have

Chronic oral steroid use of > 7.5 mg daily within the previous 30 days preceding screening

Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the 17-week study period

Summary

This trial will compare the effectiveness of using BR-AC along with standard care versus standard care alone for treating diabetic foot ulcers. The study will closely monitor wound care and healing progress using regular visits and

Who is the study for?

This trial is for individuals with non-healing diabetic foot ulcers. Participants must be able to attend weekly visits and comply with wound care instructions. Details on specific inclusion or exclusion criteria are not provided, but typically these would involve factors like the severity of the ulcer, overall health status, and any other medical conditions that might affect healing.

What is being tested?

The study compares two approaches: one group receives BR-AC plus standard care (like cleaning and bandaging), while another gets just standard care. The goal is to see if adding BR-AC improves healing. Patients who don't heal in 12 weeks with standard care can switch to try BR-AC for another 12 weeks.

What are the potential side effects?

Specific side effects of BR-AC aren't listed here, but generally treatments for foot ulcers could cause skin irritation, infection risk increase due to immune response changes, or allergic reactions depending on the components of the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My foot ulcer is shallow, without exposed muscle or bone.

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I have been diagnosed with Type 1 or Type 2 Diabetes.

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My foot ulcer is between 1 and 20 cm2 in size, located below my ankle.

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My target ulcer is at least 2 cm away from any other ulcers.

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My foot ulcer has good blood supply according to tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been taking more than 7.5 mg of oral steroids daily for the last month.

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I am not willing to use birth control or avoid pregnancy.

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I am currently using topical anti-microbial or silver-containing products.

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I have gangrene on part of my foot.

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I might have an infection in my bone or skin near a wound.

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I haven't taken steroids or chemotherapy drugs in the last 30 days.

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My ulcer shows signs of infection.

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I haven't had cancer, except for non-melanoma skin cancer, in the last 5 years.

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I am currently on dialysis or planning to start soon.

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I haven't used advanced wound treatments like enzymes or skin substitutes in the last 30 days.

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My foot ulcer exposes muscle or bone and is severe.

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My ulcer has shrunk by more than 30% after cleaning it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over the 17-week study period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over the 17-week study period

This trial's timeline: 3 weeks for screening, Varies for treatment, and over the 17-week study period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

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

+2 more

Other study objectives

DFUs that acquire clinical signs and symptoms of infections post-randomization

Proportion of subjects experiencing adverse events, by treatment group

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BR-AC plus Standard CareExperimental Treatment1 Intervention

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-AC should be applied directly to the wound surface following sharp debridement w. It is recommended that the product be trimmed to fit the area of the wound with sterile scissors before application.

Group II: Standard CarePlacebo Group1 Intervention

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.

0 / 17Eligibility criteria met