RECRUITING

A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

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

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.

Official Title

Multicenter, Prospective, Randomized, Controlled Platform Trial Assessing Clinical Utility of Cellular, Acellular and Matrix-like Products (CAMPs) and Standard of Care vs SOC Alone in Hard-to-Heal Diabetic Foot and Venous Leg Ulcers.

Quick Facts

Study Start:2024-11-18
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06453187

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 to 80 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

Karen Bartku
CONTACT
727-899-0990
karen.bartku@integralife.com
Andrew Tummon
CONTACT
609-936-5490
andrew.tummon@integralife.com

Principal Investigator

Tomas Serena, MD
PRINCIPAL_INVESTIGATOR
SerenaGroup, Inc.

Study Locations (Sites)

SerenaGroup Omaha Research Center
Omaha, Nebraska, 68114
United States
SerenaGroup Research South
Jefferson Hills, Pennsylvania, 15025
United States
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
United States
SerenaGroup Monroeville
Monroeville, Pennsylvania, 15146
United States

Collaborators and Investigators

Sponsor: Integra LifeSciences Corporation

  • Tomas Serena, MD, PRINCIPAL_INVESTIGATOR, SerenaGroup, 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 Date2024-11-18
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-11-18
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetic Foot Ulcer
  • Venous Leg Ulcer