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

Not Applicable

Completed

• Conditions: Pressure Ulcer
• Interventions: Procedure: dHACM

• Registration Number: NCT03529578
• Lead Sponsor: MiMedx Group, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-06
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-05-07
• Study First Posted: 2018-05-18
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dHACM	dHACM	Standard of Care plus Weekly Application of dHACM

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with complete wound closure of study ulcer	8 Weeks	The percentage of subjects with complete wound closure of the study ulcer

Secondary Outcome Measures

Name	Time	Method
Wound healing kinetics: Complete wound healing	8 weeks	Total time for complete wound healing
Wound healing kinetics: rate of closure/week	8 weeks	Rate of wound closure/week
Wound healing kinetics: Weekly percentage of wounds with total closure	8 weeks	Percentage of wounds with total closure at each weekly visit time point
Incidence of Treatment-Emergent Adverse Events [Safety]	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
Wound Infection Rate [Safety]	8 weeks	Additionally, wound infection rates will be noted throughout the course of the study

Trial Locations

Locations (1)

Infectious Disease Specialists of Atlanta, PC; 🇺🇸 Decatur, Georgia, United States