Diabetic Foot, Diabetic Foot Ulcer (DFU), Foot Ulcer, Ulcer Foot
Conditions
Keywords
Cellular, Acellular, Matrix-like Product (CAMP), Cellular and/or Tissue Product (CTP), Dehydrated Human Umbilical Cord (dHUC)
Brief summary
The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal diabetic foot ulcers over 12 weeks using a modified platform trial design.
Detailed description
The CORDSTIM-DFU trial is a prospective, multicenter, randomized, controlled clinical trial to evaluate two separate CAMPs (Cellular, Acellular, Matrix-like Products), Corplex P®/Allacor P™/Theracor P™ and Theracor™. The study utilizes a modified platform trial design to evaluate multiple cellular and/or tissue-based products (CTPs) in a single trial.
Interventions
OTHERStandard of Care (SOC)
Beginning at the screening visit, participants will receive weekly treatment of standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first
DEVICECorplex P
Participants will receive weekly applications of Corplex P/Allacor P/Theracor P and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
DEVICETheracor
Participants will receive weekly applications of Theracor and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
Sponsors
StimLabs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
CORDSTIM-DFU employs a modified platform clinical trial design. CORDSTIM-DFU will evaluate several CAMPs, specifically two (2) umbilical cord-based CAMPs and Standard of Care (SOC) versus SOC alone in the treatment of nonhealing diabetic foot ulcers.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age or older. 2. Diagnosis of type 1 or 2 Diabetes mellitus. 3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 15.0 cm2 measured post debridement with the MolecuLight® Imaging Device. 4. 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. 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. The target ulcer must be full thickness without exposed bone. 7. 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: a. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3; b. Toe-Brachial Index (TBI) ≥ 0.6; c. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg; d. Pulse Volume Resistance (PVR): biphasic. 8. If the potential 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. 9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment. 10. The potential subject must consent to using the prescribed offloading method for the duration of the study. 11. The potential subject must agree to attend the weekly study visits required by the protocol. 12. The potential subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of target ulcers achieving complete wound closure | 1-12 weeks | Determine the percent of target ulcers achieving complete wound closure at 12 weeks. In addition, a qualified third-party clinician will independently confirm wound closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to closure for the target ulcer | 1-12 weeks | Time to closure will be determined for each treatment group and compared to SOC. |
| Percent area reduction | 1-12 weeks | Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to Treatment Visit (TV)-13 |
| Adverse events | Time Frame: 1-14 weeks | Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV). |
| Change in pain in target ulcer | 1-14 weeks | Change in target ulcer pain assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10 where higher score indicates more severe pain and pain-related interference with life and activities) at TV-1, TV-4, TV-7, TV-10, and TV-13. |
| Determine improvement in Quality of Life - wQOL | 12 weeks | Quality of Life assessed using the Wound Quality of Life (wQOL) checklist at TV-1, TV- 4, TV-7, TV- 10, and TV-13. |
| Determine improvement in Quality of Life - FWS | 12 weeks | Quality of Life assessed using the Forgotten Wound Score (FWS) at TV-1, TV- 4, TV-7, TV- 10, and TV-13. |
Contacts
CONTACTMelissa O'Connor, MS
CONTACTKatie Lyday, RPh, MS
Outcome results
None listed