A Single Center, Prospective, Case Series of the Treatment of Pressure Ulcers and Decubitus Ulcers.

A Case Series to Investigate the Safety and Efficacy of Weekly Application of Dehydrated Human Amnion/Chorion Membrane in the Treatment of Pressure Ulcers

The purpose of this study is to investigate the efficacy and safety of dehydrated amnion/chorion membrane (dHACM) in the treatment of patients with stage II or III pressure ulcer and decubitus ulcers

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer
• Intervention / Treatment: Procedure: dHACM

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Infectious Disease Specialists of Atlanta, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Index ulcer characteristics:

   1. Index ulcer area after debridement is ≥ 2 cm² and ≤ 25 cm² at the randomization visit
   2. Ulcer must be Stage II or III as determined by the National Pressure Ulcer Advisory Panel (NPUAP) pressure ulcer staging system

2. Subject criteria must include:

   1. Age 18 or older
   2. The subject or their legally authorized representative provides consent and is willing and able to participate in all procedures and follow-up evaluations necessary to complete the study

Exclusion Criteria:

1. Index ulcer characteristics that will make subject ineligible for enrollment:

   1. Stage I or IV ulcers as determined by NPUAP pressure ulcer staging system
   2. Signs and symptoms of local infection
   3. Previous surgical procedure performed at site
   4. Known or suspected local skin malignancy at index ulcer site
   5. Prior radiation therapy treatment at the index ulcer site

2. Subject criteria that will make subject ineligible for enrollment:

   1. Presence of other diseases which, in the Opinion of the Investigator, may result in allograft failure or has experienced graft failure in the past (examples include: immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV)
   2. Currently taking medications which in the opinion of the investigator may affect graft incorporation
   3. Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
   4. Any condition(s) that in the opinion of the investigator may seriously compromises the subject's ability to participate in this study. Examples include: known history of poor adherence with medical treatment, current drug or alcohol abuse or a medical/psychiatric condition
   5. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
   6. Subjects currently enrolled in this study (i.e. concurrent enrollment in the study is prohibited)
   7. Subject has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
   8. Any pathology that would limit the blood supply and compromise healing
   9. Subject is a prisoner

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: dHACM; Standard of Care plus Weekly Application of dHACM	Procedure: dHACM; Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with complete wound closure of study ulcer	The percentage of subjects with complete wound closure of the study ulcer	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing kinetics: Complete wound healing	Total time for complete wound healing	8 weeks
Wound healing kinetics: Weekly percentage of wounds with total closure	Percentage of wounds with total closure at each weekly visit time point	8 weeks
Wound healing kinetics: rate of closure/week	Rate of wound closure/week	8 weeks
Incidence of Treatment-Emergent Adverse Events [Safety]	The endpoints for safety will be reported as the frequencies of occurrence of each adverse event, the rate of adverse events per patient/month and time to each event; Both serious and non-serious adverse events will be recorded	8 weeks
Wound Infection Rate [Safety]	Additionally, wound infection rates will be noted throughout the course of the study	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Quality of Life for subjects [Exploratory]	Comparison of Quality of Life for subjects after treatment; This data will be measured by the SF-12 Health Survey at three time points throughout the study (8 weeks): prior to treatment, at 4 weeks, and at the end of the trial.	8 weeks

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 6, 2017
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (ACTUAL): May 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Pressure Ulcer, Decubitus Ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: EFPU002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No