NCT02861560

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 5, 2016

Last Update Submit

August 22, 2018

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

  • Healing Rate

    8 weeks

Secondary Outcomes (2)

  • Adverse Events

    8 Weeks

  • Quality of Life

    8 Weeks

Study Arms (1)

dHACM

EXPERIMENTAL

Dehydrated human amnion/chorion membrane (dHACM)

Other: dHACM

Interventions

dHACMOTHER

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)

dHACM

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Index ulcer characteristics:
  • Ulcer present for ≥ 30 days (Day 0)
  • Index ulcer is located spine, lower back or buttocks
  • 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 16 or older
  • 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)

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shepherd Spine Center

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Donald Fetterolf, MD

    Chief Medical Officer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 10, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

August 24, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)