RECRUITING

Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs

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 the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.

Official Title

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.

Quick Facts

Study Start:2024-12-20
Study Completion:2027-01-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06674980

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

Bennett Rogers
CONTACT
888-960-1343
Brogers@serenagroups.com
Connie Chung, PhD
CONTACT
734-730-3058
Connie@c5biomedical.com

Principal Investigator

Thomas Serena, MD
PRINCIPAL_INVESTIGATOR
SerenaGroup, Inc.

Study Locations (Sites)

Poirot Podiatry
Metairie, Louisiana, 70001
United States

Collaborators and Investigators

Sponsor: C5 Biomedical

  • Thomas 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 Date2024-12-20
Study Completion Date2027-01-22

Study Record Updates

Study Start Date2024-12-20
Study Completion Date2027-01-22

Terms related to this study

Keywords Provided by Researchers

  • Human Placental Membrane (HPM)
  • Diabetic Foot Ulcer (DFU)
  • Venous Leg Ulcer (VLU)
  • Cellular, Acellular, and Matrix-like Product (CAMP)
  • Cellular and/or Tissue-Based Product (CTP)

Additional Relevant MeSH Terms

  • Pathologic Processes
  • Diabetes Mellitus
  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Endocrine System Disease
  • Diabetic Angiopathies
  • Vascular Diseases
  • Cardiovascular Diseases
  • Leg Ulcer
  • Skin Ulcer
  • Skin Diseases
  • Diabetes Complications
  • Diabetic Neuropathies
  • Foot Diseases
  • Diabetic Foot
  • Foot Ulcer
  • Diabetes Mellitus, Type 2
  • Ulcer
  • Foot Ulcer Unhealed