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Enrolling by Invitation

NCT Number: NCT07414368

Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate for 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.

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Key information

Conditions

Chronic Ulcers Cardiovascular Diseases DFU Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcers (DFU) Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Ulcer Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Family Foot & Ankle Specialists, LLC

Bridgeport, Connecticut, 06606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corplex P is used to cover, protect, and provide a moist wound environment

Device

Corplex P is derived from human birth tissue and used in wound management to cover, protect, and provide a moist wound environment.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percent area reduction

    Time frame: 1-12 weeks

    Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12.

  2. Time to closure for the target ulcer

    Time frame: 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.

  3. Adverse Events

    Time frame: 1-12 weeks

    Incidence of adverse events will be evaluated during each treatment visit

Sponsors and collaborators

Lead sponsor

StimLabs

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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