An observational study in Chronic Ulcers, Diabetic Foot Ulcers (DFU) and DFU, sponsored by StimLabs. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by StimLabs · Observational
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.
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.
Consecutive subjects receiving Corplex P in a real-world setting
Exclusion Criteria:
Retrospective case review of subjects receiving Corplex P
Device: Corplex P is used to cover, protect, and provide a moist wound environment
Corplex P is derived from human birth tissue and used in wound management to cover, protect, and provide a moist wound environment.
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.
Time frame: 1-12 weeks
Percent area reduction
Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12.
Time frame: 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.
Time frame: 1-12 weeks
Adverse Events
Incidence of adverse events will be evaluated during each treatment visit
Time frame: 1-12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
StimLabs