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

NCT07449988 | Not Yet Recruiting FDA Device

• 1 other identifier: CXP2603.000-M (02/26)
• Study Type: interventional
• Target: 272
• Locations: 0 countries
• Sites: N/A

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

Conditions

Venous Leg Ulcers; Venous Leg Ulcers (VLUs); Venous Leg; Leg Ulcers; Leg Ulcers Venous

Keywords

Cellular, Acellular, Matrix-like Product (CAMP); Cellular and/or Tissue Product (CTP); Dehydrated Human Umbilical Cord (dHUC)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Time to closure for the target ulcer

  1-12 weeks

• Percent area reduction

  1-12 weeks

• Change in pain in target ulcer

  1-14 weeks

• Determine improvement in Quality of Life - wQOL

  12 weeks

• Determine improvement in Quality of Life - FWS

  12 weeks

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

Standard of care will be cleaning, debridement, ulcer moisture balance, and compression therapy.

Other: Standard of Care (SOC)

Corplex P (and alternate brand names Allacor P and Theracor P)

EXPERIMENTAL

Corplex P (and alternate brand names Allacor P and Theracor P) is a dehydrated human umbilical cord-based particulate device.

Device: Corplex P

Theracor

EXPERIMENTAL

Theracor is a dehydrated human umbilical cord-based sheet device.

Device: Theracor

Interventions

Standard of Care (SOC) OTHER

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

Standard of Care

Corplex P DEVICE

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

Also known as: Allacor P and Theracor P

Corplex P (and alternate brand names Allacor P and Theracor P)

Theracor DEVICE

Participants will receive weekly applications of Theracor and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first

Theracor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age or older.
• Has a medical diagnosis of venous insufficiency with an open wound to the lower extremity.
• 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.
• 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 full thickness on the foot or leg without exposed 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:
• ABI between 0.7 and ≤ 1.3;
• TBI ≥ 0.6;
• TCOM ≥ 30 mmHg;
• PVR: biphasic.

You may not qualify if:

• Target ulcers must be treated with compression therapy for at least 14 days prior to enrollment.
• The potential subject must consent to using the prescribed compression therapy for the duration of the study.
• The potential subject must agree to attend the weekly study visits required by the protocol.
• The potential subject must be willing and able to participate in the informed consent process.
• The potential subject is known to have a life expectancy of \< 6 months.
• The target ulcer is infected or there is cellulitis in the surrounding skin.
• There is evidence of osteomyelitis or exposed bone, probes to the bone or joint capsule.
• There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
• 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).
• The potential subject is taking hydroxyurea.
• The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
• 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.
• 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.
• 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).
• Women who are pregnant or considering becoming pregnant within the next 6 months.

Sponsors & Collaborators

• StimLabs: lead

MeSH Terms

Conditions

Leg Ulcer; Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Melissa O'Connor

CONTACT

1-888-346-9802; melissa@stimlabs.com

Katie Lyday

CONTACT

1-888-346-9802; katie.lyday@stimlabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: CORDSTIM-VLU employs a modified platform clinical trial design. CORDSTIM-VLU will evaluate several CAMPs, specifically two (2) umbilical cord-based CAMPs and Standard of Care (SOC) versus SOC alone in the treatment of nonhealing venous leg ulcers.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share