Chronic Ulcers, DFU, Diabetic Foot Ulcers (DFU), Ulcer
Conditions
Brief 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.
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.
Interventions
DEVICECorplex 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.
Sponsors
StimLabs
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All consecutive subjects that received a Corplex P device application during wound management in the following retrospective cohort between February 2024 and November 2025.
Exclusion criteria
* Subjects not receiving an initial Corplex P application during treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of target ulcers achieving complete wound closure during the observational period | 1-12 weeks | Determine the percent (%) of target ulcers achieving complete wound closure at 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent area reduction | 1-12 weeks | Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12. |
| Time to closure for the target ulcer | 1-12 weeks | Time to closure (days) will be determined from the first device application to the date when the wound is first documented as fully closed. |
| Adverse Events | 1-12 weeks | Incidence of adverse events will be evaluated during each treatment visit |
Countries
United States
Outcome results
None listed