Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal DFUs (CORDSTIM-DFU)

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Umbilical CORD-Based Skin Substitutes and Standard of Care Versus Standard of Care Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot; Foot Ulcer; Ulcer Foot; Diabetic Foot Ulcer (DFU)
• Intervention / Treatment: Other: Standard of Care (SOC); Device: Corplex P; Device: Theracor

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.

• Study Type: Interventional
• Enrollment (Estimated): 272
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa O'Connor, MS; Phone Number: 1-888-346-9802; Email: melissa@stimlabs.com
• Study Contact Backup: Name: Katie Lyday, RPh, MS; Phone Number: 1-888-346-9802; Email: katie.lyday@stimlabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Exclusion Criteria:

1. The potential subject is known to have a life expectancy of < 6 months.
2. The potential subject's target ulcer is not secondary to diabetes.
3. The target ulcer is infected or there is cellulitis in the surrounding skin.
4. The target ulcer exposes tendon or bone.
5. There is evidence of osteomyelitis complicating the target ulcer.
6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
7. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
8. The potential subject is taking hydroxyurea.
9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
10. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
11. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
12. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
13. The surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.
14. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
15. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
16. The potential subject has end stage renal disease requiring dialysis.
17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
18. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
19. The target ulcer was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit. 20. The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutrition Assessment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Standard of care will be cleaning, debridement, ulcer moisture balance, and offloading.	Other: Standard 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
Experimental: Corplex P (and alternate brand names Allacor P and Theracor P); Corplex P (and alternate brand names Allacor P and Theracor P) is a dehydrated human umbilical cord-based particulate device.	Device: Corplex 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; Other Names: Allacor P and Theracor P
Experimental: Theracor; Theracor is a dehydrated human umbilical cord-based sheet device.	Device: Theracor; Participants will receive weekly applications of Theracor and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of target ulcers achieving complete wound closure	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.	1-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to closure for the target ulcer	Time to closure will be determined for each treatment group and compared to SOC.	1-12 weeks
Determine improvement in Quality of Life - wQOL	Quality of Life assessed using the Wound Quality of Life (wQOL) checklist at TV-1, TV- 4, TV-7, TV- 10, and TV-13.	12 weeks
Determine improvement in Quality of Life - FWS	Quality of Life assessed using the Forgotten Wound Score (FWS) at TV-1, TV- 4, TV-7, TV- 10, and TV-13.	12 weeks
Change in pain in target ulcer	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.	1-14 weeks
Percent area reduction	Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to Treatment Visit (TV)-13	1-12 weeks
Adverse events	Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).	Time Frame: 1-14 weeks

Collaborators and Investigators

• Sponsor: StimLabs

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cellular, Acellular, Matrix-like Product (CAMP); Cellular and/or Tissue Product (CTP); Dehydrated Human Umbilical Cord (dHUC)
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Skin and Connective Tissue Diseases; Diabetic Foot; Foot Ulcer; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: CXP2602.000-M (02/26)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No