Clinical Trial 6798

Dallas, TX 75224

Study Summary:

The objective of this clinical study is to compare the safety and effectiveness of the dermaPACE Device to sham application, when administered in conjunction with the standard of care, in the treatment of DFUs. The primary objectives of this study are to #1 assess the effectiveness (incidence of complete wound closure) of the dermaPACE and control groups 12 weeks post initial application; and #2 to determine the rate of adverse events (AEs) of the dermaPACE and control groups 24 weeks post initial application.

Qualified Participants Must:

• Be 18 years of age or older
• Have diabetes mellitus
• Have one or more chronic foot ulcers (only one will be treated) that are located in the ankle area or below, that has persisted a minimum of 30 days prior to the screening visit
• Have HbA1c ≤ 12%
• Diabetic foot ulcers ≥ 1 cm2 and ≤ 16 cm2 Ulcer Grade I or II, Stage A according to the University of Texas Diabetic Wound Classification system
• Have Ankle Brachial Index (ABI) ≥ 0.7 and ≤ 1.2, or toe pressure > 50 mmHg, or tcPO2> 40 mmHg
• Not be morbidly obese (Body Mass Index ≤ 40)
• Not be on hemodialysis
• Not have a diagnosis of foot ulcer involving osteomyelitis
• Have no evidence of prior ulcers in the same area
• Not have multiple diabetic foot ulcers on the foot that either are connected by fistulas or are within 5cm of the target ulcer
• Have foot ulcer intended for study application which cannot decrease in volume by 50% or more at the end of the two-week run-in period as compared to the screening visit

Qualified Participants May Receive:

Compensation for travel expenses, visit 2 $55.00, visits 3-10 $45.00 per visit, visits 12-16 $45.00 per visit, and visits 11 and 17 $110.00 per visit.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.