Clinical trial NCT03529578: A Single Center, Prospective, Case Series of the Treatment of Pressure Ulcers and Decubitus Ulcers.
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Pressure Ulcer, Decubitus Ulcer
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of subjects with complete wound closure of study ulcer
timeFrame: 8 Weeks
Secondary outcomes:
measure: Wound healing kinetics: Complete wound healing
timeFrame: 8 weeks
measure: Wound healing kinetics: Weekly percentage of wounds with total closure
timeFrame: 8 weeks
measure: Wound healing kinetics: rate of closure/week
timeFrame: 8 weeks
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: 8 weeks
measure: Wound Infection Rate [Safety]
timeFrame: 8 weeks
Other outcomes:
measure: Comparison of Quality of Life for subjects [Exploratory]
timeFrame: 8 weeks
Locations:
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta, PC
state: Georgia
Study officials:
affiliation: Chief Medical Officer
name: David Mason, MD
role: STUDY_DIRECTOR
References: