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.
Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of chronic wounds is extremely challenging as ulcers such as DFUs may not respond to standard of care (SOC) treatment and frequently become infected. Advanced wound products like Dehydrated Human Placental Tissue (dHPTs) have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing. This study will evaluate the clinical utility of Amnion-Intermediate-Chorion (AIC) in the closure of diabetic foot ulcers in subjects in comparison to Standard of Care treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Dehydrated 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 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.
005
Santa Rosa, California, United States
RECRUITING001
Jacksonville, Florida, United States
RECRUITING003
Chicago, Illinois, United States
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 frame: 1-12 weeks
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.
Time frame: 1-12 weeks
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.
Time frame: 1-12 weeks
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.
Time frame: 1-12 weeks
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.
Time frame: 1-12 weeks
Determine changes in Quality of Life
Changes in quality of life using both the Wound Quality of Life (wQOL) and Forgotten Wound Score (FWS) questionnaires that measure the health-related quality of life (HRQoL) of patients with chronic wounds. wQOL questionnaire is scored using a 5-point Likert scale, where 0 means "not at all" and 4 means "very much". Higher scores indicate greater impairment of quality of life. Higher the score indicates lower quality of life. \[Time Frame: Visits 2, 5, 9, and 12/Final Visit\]. FWS questionnaire measures 12 activities scored 0-4. Responses are summed and divided by the number of completed items. The mean value is then multiplied by 25 to obtain the total score of 0-100. Higher the score indicates lower quality of life. \[Time Frame: Visits 2, 5, 9, and 12/Final Visit\].
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
007
Mooresville, North Carolina, United States
RECRUITING002
Rocky Mount, North Carolina, United States
RECRUITING008
Allentown, Pennsylvania, United States
RECRUITING004
Philadelphia, Pennsylvania, United States
RECRUITING006
Hilton Head Island, South Carolina, United States
ACTIVE_NOT_RECRUITINGTime frame: 1-12 weeks