The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
The main question that this study aims to answer is:
Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment.
One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.
Subjects must be at least 18 years of age or older.
Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
The potential subject must consent to using the prescribed offloading method for the duration of the study.
The potential subject must agree to attend the weekly study visits required by the protocol.
The potential subject must be willing and able to participate in the informed consent process.
Parallel
Dual-layer perinatal tissue allograft
Other interventionThe dual-layer perinatal tissue allograft is an amnion - amnion allograft
Three-layer fenestrated perinatal tissue allograft
Other interventionThe three-layer fenestrated perinatal tissue allograft is an amnion - chorion - amnion allograft
Standard of care
Other interventionStandard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading.
Incidence of Complete Wound Closure
The percentage of wounds completely healed. Complete healing will be defined as 100% epithelialization without drainage and need for dressing or wound size ≤ 0.1cm\^2 as determined by the site investigator and validated by a blinded review board.
Time to wound closure
Time to wound closure over 12 weeks will be determined via a Kaplan-Meier analysis
Percent reduction in wound area
Percent reduction of wound area \[(Ai-Axw\]) / Ai\] x100, where Ai is the area of the index wound at randomization, Axw is the wound area at weekly intervals.
Reduction in Adverse Events
A symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries will be regarded as adverse events. Abnormal results of laboratory or diagnostic procedures are considered to be adverse events if the abnormality: 1. Results in study withdrawal. 2. Is associated with a serious adverse event. 3. Is associated with clinical signs or symptoms. 4. Leads to additional treatment or to further diagnostic tests. 5. Is considered by the Investigator to be of clinical significance
Forgotten Wound Score Measure
Forgotten Wound Score Measure
Proportion of ulcers that completely heal in patients 65 years or older
Proportion of ulcers that completely heal in patients 65 years or older for CAMP plus SOC versus SOC alone
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Samaritan Biologics
Lead sponsor
Serena Group
Collaborator
