Back to resultsA Single Center, Prospective, Case Series of the Treatment of Pressure Ulcers and Decubitus Ulcers.
Primary Purpose
Pressure Ulcer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dHACM
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcer focused on measuring Pressure Ulcer, Decubitus Ulcer
Eligibility Criteria
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
Sites / Locations
- Infectious Disease Specialists of Atlanta, PC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dHACM
Arm Description
Standard of Care plus Weekly Application of dHACM
Outcomes
Primary Outcome Measures
Percentage of subjects with complete wound closure of study ulcer
The percentage of subjects with complete wound closure of the study ulcer
Secondary Outcome Measures
Wound healing kinetics: Complete wound healing
Total time for complete wound healing
Wound healing kinetics: Weekly percentage of wounds with total closure
Percentage of wounds with total closure at each weekly visit time point
Wound healing kinetics: rate of closure/week
Rate of wound closure/week
Incidence of Treatment-Emergent Adverse Events [Safety]
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]
Additionally, wound infection rates will be noted throughout the course of the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03529578
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MiMedx Group, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Pressure Ulcer, Decubitus Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dHACM
Arm Type
Experimental
Arm Description
Standard of Care plus Weekly Application of dHACM
Intervention Type
Procedure
Intervention Name(s)
dHACM
Intervention Description
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 Outcome Measure Information:
Title
Percentage of subjects with complete wound closure of study ulcer
Description
The percentage of subjects with complete wound closure of the study ulcer
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Wound healing kinetics: Complete wound healing
Description
Total time for complete wound healing
Time Frame
8 weeks
Title
Wound healing kinetics: Weekly percentage of wounds with total closure
Description
Percentage of wounds with total closure at each weekly visit time point
Time Frame
8 weeks
Title
Wound healing kinetics: rate of closure/week
Description
Rate of wound closure/week
Time Frame
8 weeks
Title
Incidence of Treatment-Emergent Adverse Events [Safety]
Description
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
Time Frame
8 weeks
Title
Wound Infection Rate [Safety]
Description
Additionally, wound infection rates will be noted throughout the course of the study
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Comparison of Quality of Life for subjects [Exploratory]
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mason, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Infectious Disease Specialists of Atlanta, PC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Single Center, Prospective, Case Series of the Treatment of Pressure Ulcers and Decubitus Ulcers.
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