RECRUITING

IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.

Official Title

Evaluating the Efficacy of Porcine Placental Extracellular Matrix Augmented Wound Care Against Standard Wound Care for the Management of Diabetic Foot Ulcers: a Multi-center, Prospective, Observer-blinded, Randomized Controlled Clinical Trial.

Quick Facts

Study Start:2025-02-12
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06616844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Andrew Thomas
CONTACT
07767036374
andrew.thomas@convatec.com

Study Locations (Sites)

Angel City Research
Los Angeles, California, 90010
United States
Indiana Foot & Ankle
Jasper, Indiana, 47456
United States
US-FAS
Hagerstown, Maryland, 21742
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Northwell Health Comprehensive Wound Healing Center
New Hyde Park, New York, 11042
United States
US-FAS
Raleigh, North Carolina, 27609
United States

Collaborators and Investigators

Sponsor: ConvaTec Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-12
Study Completion Date2026-07

Study Record Updates

Study Start Date2025-02-12
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Wound Heal
  • Ulcer