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.
In 2020, more than 4.5 billion people around the world were estimated to have chronic venous disease stages C1-C6, and approximately 3 in every 1000 people globally develop a VLU annually. While the pathophysiology of VLUs is complex, risk factors are thought to include noncompliance with compression therapy, incorrect ulcer diagnosis, obesity, and a history of deep vein thrombosis. It is estimated that 7% of VLUs do not heal within a 12-month period. As with DFUs, treatment of VLUs focuses on prevention. Low-income individuals, especially those from minority communities, often face difficulties in accessing advanced wound care centers. The estimated annual cost of treating VLUs in the United States in 2022 was over $4.9 billion, which includes expenses for practitioners, wound care products, hospital stays, medications, and compression therapy. Despite the well-established standard of care for chronic wounds, which includes sharp debridement, offloading, compression therapy, and maintaining proper moisture balance, a notable gap remains between clinical outcomes and desired results in chronic wound care. The reported recurrence rate for venous leg ulcers (VLUs) also ranges from 24% - 57%, illustrating the long-term burden this pathology places on patients. One approach to treating chronic wounds involves the use of cellular, acellular, and matrix-like products (CAMPs), which are defined as 'A broad category of biomaterials, synthetic materials, or biosynthetic matrices that support repair or regeneration of injured tissues through various mechanisms of action. The application of CAMPs in chronic wound treatment provides several benefits, including creating a protective environment for healing, covering deep structures, aiding surgical closure, enhancing functional outcomes, and improving appearance. The cellular category of CAMPS includes allografts, which are human donor tissue samples intended for use in other human patients. Utilizing dehydrated human placental tissue (dHPT) as an allograft displays considerable promise for chronic wound treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Dehydrated 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 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 frame: 1-10 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: 1-10 weeks
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.
Time frame: 1-10 weeks
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.
Time frame: 1-10 weeks
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