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

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 Venous Leg 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 venous leg ulcers over 12 weeks using a modified platform trial design.

Study Overview

• Status: Not yet recruiting
• Conditions: Leg Ulcers; Venous Leg Ulcers; Leg Ulcers Venous; Venous Leg; Venous Leg Ulcers (VLUs)
• Intervention / Treatment: Other: Standard of Care (SOC); Device: Corplex P; Device: Theracor

Detailed Description

The CORDSTIM-VLU 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; Phone Number: 1-888-346-9802; Email: melissa@stimlabs.com
• Study Contact Backup: Name: Katie Lyday; 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. Has a medical diagnosis of venous insufficiency with an open wound to the lower extremity.
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 full thickness on the foot or leg without exposed bone.

6. 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 between 0.7 and ≤ 1.3;
   2. TBI ≥ 0.6;
   3. TCOM ≥ 30 mmHg;
   4. PVR: biphasic.
7. 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.
8. Target ulcers must be treated with compression therapy for at least 14 days prior to enrollment.
9. The potential subject must consent to using the prescribed compression therapy for the duration of the study.
10. The potential subject must agree to attend the weekly study visits required by the protocol.
11. 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 target ulcer is infected or there is cellulitis in the surrounding skin.
3. There is evidence of osteomyelitis or exposed bone, probes to the bone or joint capsule.
4. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
5. 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).
6. The potential subject is taking hydroxyurea.
7. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
8. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper treatment of the target ulcer.
9. If the subject is diabetic and has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
10. The surface area of the target ulcer has reduced in size by more than 25% in the 2 weeks prior to the initial screening visit ("historical" run-in period) or the 2 weeks from the initial screening visit (SV1) to the TV1/randomization visit during which time the subject received SOC. 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).
11. Women who are pregnant or considering becoming pregnant within the next 6 months.
12. The potential subject has end stage renal disease requiring dialysis.
13. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
14. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
15. 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.
16. 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 compression therapy.	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
Adverse events	Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).	1-14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to closure for the target ulcer	Time to closure will be determined for each treatment group and compared to SOC	1-12 weeks
Percent area reduction	Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to Treatment Visit (TV)-13	1-12 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: Vascular Diseases; Cardiovascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Skin and Connective Tissue Diseases; Varicose Ulcer; Leg 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: CXP2603.000-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