Chronic UlcersNCT07414368
Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate for Acute and Chronic Wounds
An observational study of Chronic Ulcers and Diabetic Foot Ulcers (DFU), run by StimLabs at 1 site in United States.
Trial summary
The purpose of this observational case series is to assess the use of Corplex P as a resorbable particulate device used to cover, protect, and provide a moist wound environment when added to the standard of care treatment of hard-to-heal wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Ulcers, Diabetic Foot Ulcers (DFU), DFU
- What is being tested?
- Corplex P is used to cover, protect, and provide a moist wound environment
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2026to Jul 2026
- Phase
- Observational
- 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
Study population: Consecutive subjects receiving Corplex P in a real-world setting
Who may be able to join
- All consecutive subjects that received a Corplex P device application during wound management in the following retrospective cohort between February 2024 and November 2025.
Who cannot join
- Subjects not receiving an initial Corplex P application during treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Family Foot & Ankle Specialists, LLC
Bridgeport, Connecticut, 06606
About this study
Official title: A Retrospective, Single-center Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate Used for Treatment in Acute and Chronic Wounds
The purpose of this observational case series is to assess the use of Corplex P as a resorbable particulate device used to cover, protect, and provide a moist wound environment when added to the standard of care treatment of hard-to-heal wounds.
Read the detailed description
This is a retrospective, single-center observational case series to assess real-world outcomes of StimLabs dehydrated human umbilical cord particulate used in the management of hard-to-heal wounds, including acute and chronic ulcers. This case series will include real-world data from up to 10 subjects at one participating site. The Corplex P product has been utilized in a variety of patients attending wound clinics for management of partial and full-thickness wounds, pressure ulcers, venous leg ulcers (VLU), diabetic foot ulcers (DFUs), chronic vascular ulcers, and surgical wounds. The device is intended to cover, protect, and provide a moist wound environment. Medical records will be reviewed for subjects who received the Corplex P product, and data will be collected from baseline, first presentation, treatment, and follow up data. Data summaries will review wound closure, percent are reduction in wound size over treatment time, number of device applications required during treatment, time to wound closure, and adverse events.
- Conditions
- Chronic Ulcers, Diabetic Foot Ulcers (DFU), DFU, Ulcer
- Being tested
- Corplex P is used to cover, protect, and provide a moist wound environment
- Medical subject headings
- Diabetic Foot, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corplex P is used to cover, protect, and provide a moist wound environmentDevice
Corplex P is derived from human birth tissue and used in wound management to cover, protect, and provide a moist wound environment.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Corplex P | Retrospective case review of subjects receiving Corplex P Receives: Device: Corplex P is used to cover, protect, and provide a moist wound environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of target ulcers achieving complete wound closure during the observational period
Determine the percent (%) of target ulcers achieving complete wound closure at 12 weeks.
Measured: 1-12 weeks
Secondary outcomes (3)
Percent area reduction
Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12.
Measured: 1-12 weeks
Time to closure for the target ulcer
Time to closure (days) will be determined from the first device application to the date when the wound is first documented as fully closed.
Measured: 1-12 weeks
Adverse Events
Incidence of adverse events will be evaluated during each treatment visit
Measured: 1-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start11 Feb 2026
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- StimLabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414368
- Sponsor's protocol ID
- CXP2601.000-M(01/26)
- Status last verified
- Dec 2025
- First submitted
- 9 Feb 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Single-center Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate Used for Treatment in Acute and Chronic Wounds
- ClinicalTrials.gov ID
- NCT07414368
- Acronym / sponsor ID
- CXP2601.000-M(01/26)
- Conditions
- Chronic Ulcers, Diabetic Foot Ulcers (DFU), DFU, Ulcer
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- StimLabsIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 Feb 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 observational case series is to assess the use of Corplex P as a resorbable particulate device used to cover, protect, and provide a moist wound environment when added to the standard of care treatment of hard-to-heal wounds.
Detailed description
This is a retrospective, single-center observational case series to assess real-world outcomes of StimLabs dehydrated human umbilical cord particulate used in the management of hard-to-heal wounds, including acute and chronic ulcers. This case series will include real-world data from up to 10 subjects at one participating site. The Corplex P product has been utilized in a variety of patients attending wound clinics for management of partial and full-thickness wounds, pressure ulcers, venous leg ulcers (VLU), diabetic foot ulcers (DFUs), chronic vascular ulcers, and surgical wounds. The device is intended to cover, protect, and provide a moist wound environment. Medical records will be reviewed for subjects who received the Corplex P product, and data will be collected from baseline, first presentation, treatment, and follow up data. Data summaries will review wound closure, percent are reduction in wound size over treatment time, number of device applications required during treatment, time to wound closure, and adverse events.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Corplex P | – | Device: Corplex P is used to cover, protect, and provide a moist wound environmentRetrospective case review of subjects receiving Corplex P |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive subjects receiving Corplex P in a real-world setting
Key inclusion criteria (1 listed)
- All consecutive subjects that received a Corplex P device application during wound management in the following retrospective cohort between February 2024 and November 2025.
Key exclusion criteria (1 listed)
- Subjects not receiving an initial Corplex P application during treatment
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 |
|---|---|---|
| Corplex P is used to cover, protect, and provide a moist wound environmentCorplex P is derived from human birth tissue and used in wound management to cover, protect, and provide a moist wound environment. | Device | Retrospective Corplex P |
Primary outcome
The proportion of target ulcers achieving complete wound closure during the observational period
Time frame: 1-12 weeks
Determine the percent (%) of target ulcers achieving complete wound closure at 12 weeks.
3 secondary outcomes
Percent area reduction
Time frame: 1-12 weeks
Time to closure for the target ulcer
Time frame: 1-12 weeks
Adverse Events
Time frame: 1-12 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 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Ulcers and Diabetic Foot Ulcers (DFU), run by StimLabs at 1 site in United States.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of target ulcers achieving complete wound closure during the observational period (time frame: 1-12 weeks). 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 28 Apr 2026.