Pressure UlcerNCT03529578
A Single Center, Prospective, Case Series of the Treatment of Pressure Ulcers and Decubitus Ulcers.
A study testing dHACM in people with Pressure Ulcer, run by MiMedx Group, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- dHACM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Infectious Disease Specialists of Atlanta, PC
Decatur, Georgia, 30033
About this study
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
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
- Being tested
- dHACM
- Keywords
- Pressure Ulcer, Decubitus Ulcer
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dHACMProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| dHACM | Experimental | Standard of Care plus Weekly Application of dHACM Receives: Procedure: dHACM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with complete wound closure of study ulcer
The percentage of subjects with complete wound closure of the study ulcer
Measured: 8 Weeks
Secondary outcomes (5)
Wound healing kinetics: Complete wound healing
Total time for complete wound healing
Measured: 8 weeks
Wound healing kinetics: Weekly percentage of wounds with total closure
Percentage of wounds with total closure at each weekly visit time point
Measured: 8 weeks
Wound healing kinetics: rate of closure/week
Rate of wound closure/week
Measured: 8 weeks
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
Measured: 8 weeks
Wound Infection Rate [Safety]
Additionally, wound infection rates will be noted throughout the course of the study
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start6 Jun 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MiMedx Group, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Mason, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529578
- Sponsor's protocol ID
- EFPU002
- Status last verified
- Nov 2020
- First submitted
- 20 Mar 2018
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03529578
- Acronym / sponsor ID
- EFPU002
- Conditions
- Pressure Ulcer
- Keywords
- Pressure Ulcer, Decubitus Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MiMedx Group, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dHACM | Experimental | Procedure: dHACMStandard of Care plus Weekly Application of dHACM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Index ulcer characteristics:
- Subject criteria must include:
Key exclusion criteria (16 listed)
- Index ulcer characteristics that will make subject ineligible for enrollment:
- Subject criteria that will make subject ineligible for enrollment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dHACMDehydrated 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) | Procedure or surgery | dHACM |
Primary outcome
Percentage of subjects with complete wound closure of study ulcer
Time frame: 8 Weeks
The percentage of subjects with complete wound closure of the study ulcer
5 secondary outcomes
Wound healing kinetics: Complete wound healing
Time frame: 8 weeks
Wound healing kinetics: Weekly percentage of wounds with total closure
Time frame: 8 weeks
Wound healing kinetics: rate of closure/week
Time frame: 8 weeks
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: 8 weeks
Wound Infection Rate [Safety]
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Mason, MD study director
Chief Medical Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dHACM in people with Pressure Ulcer, run by MiMedx Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with complete wound closure of study ulcer (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.