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 venous leg ulcers.
18 years of age or older.
Hemoglobin A1c (HbA1c) level is <12% (108 mmol/mol).
Target ulcer with a surface area of between 1.0 cm 2 and 25.0 cm 2 measured post debridement at randomization.
Target ulcer must have been present for a minimum of 4 weeks with standard of care prior to the initial screening visit.
The participant must agree to attend the weekly study visits required by the protocol.
The participant must be willing and able to participate in the informed consent process
Known life expectancy of <6 months.
Target ulcer is infected or there is cellulitis in the surrounding skin.
Crossover
Amnion-Intermediate-Chorion
Other interventionDehydrated human placental multilayer allograft derived from 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 Venous Leg Ulcers with Complete Wound Closure
The percentage of VLU 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 10 will be calculated weekly from measurements with digital photographic images and physical examination.
Incidents of Adverse Events
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. 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.
Changes in 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 10. VAS is a tool that uses a 0-10 (no o extreme pain) point scale to measure pain intensity.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
