NCT07414368

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

February 9, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 28, 2026

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

February 9, 2026

Last Update Submit

April 22, 2026

Conditions

Chronic UlcersDiabetic Foot Ulcers (DFU)DFUUlcer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Percent area reduction

    1-12 weeks

  • Time to closure for the target ulcer

    1-12 weeks

  • Adverse Events

    1-12 weeks

Study Arms (1)

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

Interventions

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

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

Retrospective Corplex P

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive subjects receiving Corplex P in a real-world setting

You may qualify if:

  • All consecutive subjects that received a Corplex P device application during wound management in the following retrospective cohort between February 2024 and November 2025.

You may not qualify if:

  • Subjects not receiving an initial Corplex P application during treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Foot & Ankle Specialists, LLC

Bridgeport, Connecticut, 06606, United States

Location

MeSH Terms

Conditions

Diabetic FootUlcer

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

February 11, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 28, 2026

Record last verified: 2025-12

Locations

US(1)