Diabetic Foot Ulcer, Venous Leg Ulcer
Conditions
Keywords
diabetic foot ulcer, venous leg ulcer, DFU, VLU, ulcer
Brief summary
The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and venous leg ulcers.
Detailed description
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 and Venous Leg Ulcers (VLUs) may not respond to standard of care (SOC) treatment and frequently become infected. Advanced wound products like CAMPs 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 Multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment.
Interventions
Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
OTHERAmnion-Chorion-Amnion
Dehydrated human placental trilayer allograft derived from donated human tissue.
PROCEDUREStandard of Care
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.
Sponsors
Cellution Biologics
SerenaGroup, Inc.
LifeCell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 98 Years
Healthy volunteers
No
Inclusion criteria
for DFU: Potential subjects are required to meet all the following criteria for enrollment into the study and subsequent randomization. * 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 0.7 cm2 and a maximum surface area of 5.0 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. * The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. * The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone. * The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable: 1. ABI ≥ 0.7 and ≤ 1.3; 2. TBI ≥ 0.6; 3. TCOM ≥ 40 mmHg; 4. PVR: biphasic. * If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the target ulcer. * The subject must consent to using the prescribed off-loading method for the duration of the study. * The subject must agree to attend the weekly study visits required by the protocol. * The subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of ulcers with complete wound closure | 1-12 weeks | The percentage of DFU and VLU target ulcers achieving complete wound closure. Closure is defined by 100% re-epithelialization of the ulcer surface without detectable exudate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete closure for ulcer | 1-12 weeks | Time to closure will be determined for each 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 | 1-12 weeks | Percentage wound area changes from week 1 to week 12 will be calculated weekly from measurements with digital photographic planimetry and physical examination. |
| Incidence of Adverse events | 1-12 weeks | The incidence of adverse events will be evaluated weekly from the first study visit to wound healing and/or final visit. |
| Changes to pain associated with the target ulcer | 1-12 weeks | 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. |
| Determine changes in Quality of Life | 1-12 weeks | 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. \[Time Frame: Visits 1, 4, 8, and 12/Final Visit\]. 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. \[Time Frame: Visits 1, 4, 8, and 12/Final Visit\]. |
Countries
United States
Outcome results
None listed