NCT03044132

Brief Summary

This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

January 15, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

February 1, 2017

Last Update Submit

September 3, 2019

Conditions

Diabetic Foot UlcerLower Extremity Wound

Keywords

Diabetic Foot UlcerDFULower Extremity WoundSkin Substitute

Outcome Measures

Primary Outcomes (1)

  • Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).

    Days required for granular bed formation

    112 Days

Secondary Outcomes (3)

  • Number of applications of study product required to achieve granulation.

    16 Weeks

  • Percent wound area reduction and percent complete wound closure at 16 Weeks.

    16 Weeks

  • The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.

    16 Weeks

Study Arms (1)

DermACELL AWM

EXPERIMENTAL

Human acellular dermal matrix (ADM) recovered from human donors, decellularized, provided with at least 97% DNA removal, terminally sterilized in its final package, and ready to use.

Other: DermACELL AWM

Interventions

DermACELL AWMOTHER

Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology

DermACELL AWM

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
  • target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration)
  • target wound that is not amendable to primary closure
  • target wound deemed without any residual infection (as assessed by Investigator) or is being treated upon entry into the clinical trial
  • adequate perfusion to the extremity
  • laboratory assessments which represent a good potential for wound healing (liver and kidney function, nutritionally stable and diabetes control)

You may not qualify if:

  • untreated infection of soft tissue or bone
  • untreated autoimmune connective tissue disorders
  • body mass index (BMI) of ≥ 50
  • undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication
  • active liver disease (e.g. hepatitis A-G),
  • have undergone previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment
  • pregnant
  • enrolled in any other interventional clinical research trial
  • an increase or decrease of more than 25% in wound area or volume from the Screening to Baseline visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Limb Preservation Platform

Fresno, California, 93710, United States

Location

Purvis Moyer Foot and Ankle Center

Rocky Mount, North Carolina, 27804, United States

Location

Related Publications (1)

  • Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA. A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Adv Skin Wound Care. 2019 Sep;32(9):409-415. doi: 10.1097/01.ASW.0000569132.38449.c0.

    PMID: 31361269RESULT

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 6, 2017

Study Start

January 15, 2017

Primary Completion

April 30, 2018

Study Completion

December 31, 2018

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)