Venous Leg UlcersCORDSTIM-VLUNCT07449988
Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal VLUs
A study testing Corplex P and Theracor in people with Venous Leg Ulcers and Venous Leg Ulcers (VLUs), run by StimLabs.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcers, Venous Leg Ulcers (VLUs), Venous Leg
- What is being tested?
- Corplex P and Theracor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- ABI between 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 30 mmHg;
- PVR: biphasic.
- 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.
- 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.
Who cannot join
- 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.
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- 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.
- The potential subject has end stage renal disease requiring dialysis.
- Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
- A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
- 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.
- The potential subject has a malnutrition indicator score <17 as measured on the Mini Nutrition Assessment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Standard of Care (SOC), Corplex P, Theracor
- Keywords
- Cellular, Acellular, Matrix-like Product (CAMP), Cellular and/or Tissue Product (CTP), Dehydrated Human Umbilical Cord (dHUC)
- Medical subject headings
- Leg Ulcer, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Corplex PDevice
Also called Allacor P and Theracor 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
TheracorDevice
Participants will receive weekly applications of Theracor and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of care will be cleaning, debridement, ulcer moisture balance, and compression therapy. Receives: 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. Receives: Device: Corplex P |
| Theracor | Experimental | Theracor is a dehydrated human umbilical cord-based sheet device. Receives: Device: Theracor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-12 weeks
Adverse events
Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).
Measured: 1-14 weeks
Secondary outcomes (5)
Time to closure for the target ulcer
Time to closure will be determined for each treatment group and compared to SOC
Measured: 1-12 weeks
Percent area reduction
Percent Area Reduction (PAR) will be calculated from Treatment Visit (TV)-1 to Treatment Visit (TV)-13
Measured: 1-12 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.
Measured: 1-14 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- StimLabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449988
- Sponsor's protocol ID
- CXP2603.000-M (02/26)
- Acronym
- CORDSTIM-VLU
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07449988
- Acronym / sponsor ID
- CORDSTIM-VLU / CXP2603.000-M (02/26)
- Keywords
- Cellular, Acellular, Matrix-like Product (CAMP), Cellular and/or Tissue Product (CTP), Dehydrated Human Umbilical Cord (dHUC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- StimLabsIndustry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of Care (SOC)Standard of care will be cleaning, debridement, ulcer moisture balance, and compression therapy. |
| Corplex P (and alternate brand names Allacor P and Theracor P) | Experimental | Device: Corplex PCorplex P (and alternate brand names Allacor P and Theracor P) is a dehydrated human umbilical cord-based particulate device. |
| Theracor | Experimental | Device: TheracorTheracor is a dehydrated human umbilical cord-based sheet device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Standard of Care |
| Corplex PAlso: Allacor P and Theracor PParticipants 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 | Device | Corplex P (and alternate brand names Allacor P and Theracor P) |
| TheracorParticipants will receive weekly applications of Theracor and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first | Device | Theracor |
Primary outcome
The percentage of target ulcers achieving complete wound closure
Time frame: 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.
Adverse events
Time frame: 1-14 weeks
Incidence of adverse events will be evaluated weekly from TV-1 to the healing confirmation visit (HCV).
5 secondary outcomes
Time to closure for the target ulcer
Time frame: 1-12 weeks
Percent area reduction
Time frame: 1-12 weeks
Change in pain in target ulcer
Time frame: 1-14 weeks
Determine improvement in Quality of Life - wQOL
Time frame: 12 weeks
Determine improvement in Quality of Life - FWS
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Corplex P and Theracor in people with Venous Leg Ulcers and Venous Leg Ulcers (VLUs), run by StimLabs.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa O'Connor (1-888-346-9802, melissa@stimlabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of target ulcers achieving complete wound closure (time frame: 1-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.