Diabetic Foot Ulcer
Conditions
Keywords
DFU, Diabetic Ulcer, Foot Wound, Diabetic Foot Ulcer, Placenta
Brief summary
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.
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 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.
Interventions
Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
PROCEDUREStandard of Care (SOC)
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will be eligible to participate in the study if the following conditions exist: Inclusion Criteria: 1. 18 years of age or older. 2. Diagnosis of type 1 or 2 Diabetes mellitus. 3. Hemoglobin A1c (HbA1c) level is \< 12% (108 mmol/mol). 4. Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement. 5. Target ulcer present for minimum of 4 weeks prior to screening visit. 6. Target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 7. 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. 8. Affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the screening visit are acceptable: 1. ABI ≥ 0.7 and ≤ 1.3; 2. TBI ≥ 0.6; 3. TCOM ≥ 40 mmHg; 4. PVR: biphasic or triphasic. 9. Subject with two or more ulcers must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the target ulcer. 10. Subject must consent to using the prescribed off-loading method for the duration of the study. 11. Subject must agree to attend study visits required by the protocol. 12. 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 target ulcers achieving complete wound closure. Closure is defined as 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 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 | 1-12 weeks | Percentage wound area changes from week 1 to week 12 will be calculated weekly from measurements with digital photographic images and physical examination. |
| 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. |
| 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. |
| 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. \[Time Frame: Visits 2, 5, 9, and 12/Final Visit\]. 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. \[Time Frame: Visits 2, 5, 9, and 12/Final Visit\]. |
Countries
United States
Contacts
STUDY_DIRECTORResearch Director
Cellution Biologics
Outcome results
None listed