The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.
18 years of age or older.
Diagnosis of type 1 or 2 Diabetes mellitus.
Hemoglobin A1c (HbA1c) level is < 12% (108 mmol/mol).
Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.
Subject must consent to using the prescribed off-loading method for the duration of the study.
Subject must agree to attend study visits required by the protocol.
Subject must be willing and able to participate in the informed consent process.
Known life expectancy of < 6 months.
Parallel
Amnion-Intermediate-Chorion
Other interventionDehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
Standard of Care (SOC)
Procedure/SurgeryStandard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
Percentage of ulcers with complete wound closure
The percentage of DFU target ulcers achieving complete wound closure. Closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate.
Time to complete closure for ulcer
Time to closure will be determined for the treatment group and compared to Standard of Care. Closure is defined by 100% re-epithelialization of the ulcer surface without detectable exudate.
Percentage of wound area change for target ulcer
Percentage wound area changes from week 1 to week 12 will be calculated weekly from measurements with digital photographic images and physical examination.
Changes to pain associated with the target ulcer
Change in pain in the target ulcer assessed using the Visual Analog Scale (VAS) from week 1 to week 12. VAS is a tool that uses a 0-10 (no to extreme pain) point scale to measure pain intensity.
Incidence of Adverse events
The incidence of adverse events will be evaluated weekly from the first study visit to wound healing and/or final visit.
Percentage of ulcers with complete wound closure for subjects 65 years or older
The percentage of DFU target ulcers in subjects 65 years or older achieving complete wound closure. Closure is defined by 100% re-epithelialization of the ulcer surface without detectable exudate.
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