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OpenTrials
Completed

NCT Number: NCT03529578

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Infectious Disease Specialists of Atlanta, PC

Decatur, Georgia, 30033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Index ulcer characteristics:
  • Index ulcer area after debridement is ≥ 2 cm² and ≤ 25 cm² at the randomization visit
  • Ulcer must be Stage II or III as determined by the National Pressure Ulcer Advisory Panel (NPUAP) pressure ulcer staging system
  • Subject criteria must include:
  • Age 18 or older
  • 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

  • Index ulcer characteristics that will make subject ineligible for enrollment:
  • Stage I or IV ulcers as determined by NPUAP pressure ulcer staging system
  • Signs and symptoms of local infection
  • Previous surgical procedure performed at site
  • Known or suspected local skin malignancy at index ulcer site
  • Prior radiation therapy treatment at the index ulcer site
  • Subject criteria that will make subject ineligible for enrollment:
  • 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)
  • Currently taking medications which in the opinion of the investigator may affect graft incorporation
  • Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
  • 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
  • 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)
  • Subjects currently enrolled in this study (i.e. concurrent enrollment in the study is prohibited)
  • Subject has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
  • Any pathology that would limit the blood supply and compromise healing
  • Subject is a prisoner

Treatment and study plan

dHACM

Procedure

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)

Primary outcomes

  1. Percentage of subjects with complete wound closure of study ulcer

    Time frame: 8 Weeks

    The percentage of subjects with complete wound closure of the study ulcer

Secondary outcomes

  1. Wound healing kinetics: Complete wound healing

    Time frame: 8 weeks

    Total time for complete wound healing

  2. Wound healing kinetics: Weekly percentage of wounds with total closure

    Time frame: 8 weeks

    Percentage of wounds with total closure at each weekly visit time point

  3. Wound healing kinetics: rate of closure/week

    Time frame: 8 weeks

    Rate of wound closure/week

  4. Incidence of Treatment-Emergent Adverse Events [Safety]

    Time frame: 8 weeks

    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

  5. Wound Infection Rate [Safety]

    Time frame: 8 weeks

    Additionally, wound infection rates will be noted throughout the course of the study

Other outcomes

  1. Comparison of Quality of Life for subjects [Exploratory]

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

MiMedx Group, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 18, 2018
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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