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

NCT03529578 | Completed DMC

• 1 other identifier: EFPU002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pressure Ulcer

Keywords

Pressure Ulcer, Decubitus Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Wound healing kinetics: Complete wound healing

  8 weeks

• Wound healing kinetics: Weekly percentage of wounds with total closure

  8 weeks

• Wound healing kinetics: rate of closure/week

  8 weeks

• Incidence of Treatment-Emergent Adverse Events [Safety]

  8 weeks

• Wound Infection Rate [Safety]

  8 weeks

Other Outcomes (1)

• Comparison of Quality of Life for subjects [Exploratory]

  8 weeks

Study Arms (1)

dHACM

EXPERIMENTAL

Standard of Care plus Weekly Application of dHACM

Procedure: dHACM

Interventions

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)

dHACM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (1)

Infectious Disease Specialists of Atlanta, PC

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Mason, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: May 18, 2018
• Study Start: June 6, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (1)