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Enrolling by invitation NCT07414368

Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate for Acute and Chronic Wounds

Observational Chronic Ulcers Diabetic Foot Ulcers (DFU) DFU Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Corplex P is used to cover, protect, and provide a moist wound environment.
Who it may be relevant to
Registry conditions: Chronic Ulcers, Diabetic Foot Ulcers (DFU), DFU, Ulcer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Retrospective, Single-center Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate Used for Treatment in Acute and Chronic Wounds

Overview

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

  • 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.

Primary outcome measures

  • The proportion of target ulcers achieving complete wound closure during the observational period [Time frame: 1-12 weeks]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Family Foot & Ankle Specialists, LLC — Bridgeport

Identifiers

NCT: NCT07414368 · CXP2601.000-M(01/26)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗