Pressure Ulcer
Conditions
Keywords
Pressure Ulcer, Decubitus Ulcer
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
Interventions
PROCEDUREdHACM
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)
Sponsors
MiMedx Group, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Wound healing kinetics: Complete wound healing | 8 weeks | Total time for complete wound healing |
| 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 |
| Wound healing kinetics: rate of closure/week | 8 weeks | Rate of wound closure/week |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Quality of Life for subjects [Exploratory] | 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. |
Countries
United States
Outcome results
None listed