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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ulcer; Chronic Ulcers; Diabetic Foot Ulcers (DFU); DFU
• Intervention / Treatment: Device: Corplex P is used to cover, protect, and provide a moist wound environment

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 Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Family Foot & Ankle Specialists, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive subjects receiving Corplex P in a real-world setting

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective Corplex P; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent area reduction	Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12.	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.	1-12 weeks
Adverse Events	Incidence of adverse events will be evaluated during each treatment visit	1-12 weeks

Collaborators and Investigators

• Sponsor: StimLabs

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Ulcer; Diabetic Foot
• Other Study ID Numbers: CXP2601.000-M(01/26)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No