A Single Center, Prospective, Case Series of the Treatment of Pressure Ulcers and Decubitus Ulcers.

NCT ID: NCT03529578

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-06
• Study Completion Date: 2019-06-01

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

Conditions

Pressure Ulcer

Keywords

Pressure Ulcer, Decubitus Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dHACM

Standard of Care plus Weekly Application of dHACM

Group Type: EXPERIMENTAL

dHACM

Intervention Type: PROCEDURE

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)

Interventions

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)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MiMedx Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Mason, MD

Role: STUDY_DIRECTOR

Chief Medical Officer

Locations

Infectious Disease Specialists of Atlanta, PC

Decatur, Georgia, United States

Countries

United States

Other Identifiers

EFPU002

Identifier Type: -

Identifier Source: org_study_id