1. Trial Details/Purpose

Diabetic foot ulcers (DFUs) affect about 15% of people with diabetes, leading to approximately 500,000 new cases annually in the U.S. They are a major cause of lower-limb amputations, costing $9 billion annually. Healing time ranges from 6 weeks to several months. Venous leg ulcers (VLUs) impact 1-2% of adults, with 500,000 to 2 million cases in the U.S. Recurrence rates are high. Both conditions present significant healthcare challenges.  The STABLECAMP trial is a clinical study designed to evaluate the effectiveness of various advanced wound care products, referred to as Cellular, Acellular, and Matrix-like Products (CAMPs), in combination with standard care, compared to standard care alone, for treating non-healing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The primary goal is to determine if adding these products to standard care can improve the healing rates of these chronic wounds over a 12-week period.​

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​2. Inclusion Criteria

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• Age and Health Status: Adults aged 18 years or older with a diagnosis of a non-healing DFU or VLU.

• Wound Characteristics: Ulcers that have not healed with standard care and meet specific size and duration criteria as defined by the study protocol.

 

3. Exclusion Criteria

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• Infection Status: Ulcers with active infection that require systemic antibiotic treatment.

• Circulation Issues: Participants with severe peripheral arterial disease or other conditions that significantly impair blood flow to the affected area.

• Other Health Conditions: Individuals with medical conditions that could interfere with wound healing or pose a risk during the study, as determined by the investigators.

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​4. Benefits of Participation

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• Participants may be compensated for time and travel.

• No personal insurance is necessary.

• Participants will receive study medication at no cost.

• Before and during the study, qualified participants will meet with board-certified physicians and highly-trained and skilled research staff and receive one-on-one care.

 

​5. Study Location (s)​

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     Huntington Park | Tarzana