Case Series of Weekly Applications of dHACM in Treatment of Pressure Ulcers

Pressure Ulcer Clinical Trial

Official title:

A Case Series to Investigate the Safety and Efficacy of Weekly Application of Dehydrated Human Amnion/Chorion Membrane (dHACM) in the Treatment of Pressure Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861560
• Other study ID #: EFPU001
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: August 2018
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective case series investigating the efficacy and safety of dehydrated human amnion/chorion membrane (dHACM) in the treatment of patients with Stage II or III pressure ulcers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Index ulcer characteristics:

1. Ulcer present for = 30 days (Day 0)

2. Index ulcer is located spine, lower back or buttocks

3. Index ulcer area after debridement is = 2 cm² and = 25 cm² at the randomization visit

4. 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 16 or older

2. The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study (minors will provide assent with consent provided by parent)

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Other:
• dHACM
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)

Locations

Country	Name	City	State
United States	Shepherd Spine Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing Rate		8 weeks
Secondary	Adverse Events		8 Weeks
Secondary	Quality of Life	SF-36 Health Survey	8 Weeks