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A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Primary Purpose

Foot Ulcer, Diabetic

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PriMatrix
Standard of Care
Sponsored by
Integra LifeSciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women ≥ 18 years of age and able to give their own consent
  • Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
  • Study ulcer has a Wagner grade of 1 or 2
  • Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement
  • A full thickness diabetic foot ulcer located on the foot or ankle
  • An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening.

Exclusion Criteria:

  • Suspected or confirmed signs/symptoms of wound infection
  • Wounds with exposed bone or tendon
  • Hypersensitivity to bovine collagen

Sites / Locations

  • HyperbaRXs
  • Covenant Medical Center
  • Professional Hospital
  • Dr. Pila Metropolitan Hospital Wound Healing Center
  • Caribbean Clinical Trials
  • Doctors' Center Hospital of San Juan
  • Wound and Ulcer Care Clinic of San Juan
  • Wilma N. Vazquez Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Treatment

Standard of Care

Arm Description

PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy.

Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained.

Outcomes

Primary Outcome Measures

Percent of study ulcers healed
Percent of study ulcers healed at week 12 post-randomization

Secondary Outcome Measures

Cost of Treatment

Full Information

First Posted
January 4, 2011
Last Updated
November 30, 2017
Sponsor
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01270633
Brief Title
A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
Official Title
A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Business Decision
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.
Detailed Description
Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained.
Intervention Type
Device
Intervention Name(s)
PriMatrix
Intervention Description
Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Following sharp debridement, moist wound therapy
Primary Outcome Measure Information:
Title
Percent of study ulcers healed
Description
Percent of study ulcers healed at week 12 post-randomization
Time Frame
12 weeks post-randomization
Secondary Outcome Measure Information:
Title
Cost of Treatment
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women ≥ 18 years of age and able to give their own consent Type I or Type II diabetes with investigator-confirmed reasonable metabolic control Study ulcer has a Wagner grade of 1 or 2 Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement A full thickness diabetic foot ulcer located on the foot or ankle An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening. Exclusion Criteria: Suspected or confirmed signs/symptoms of wound infection Wounds with exposed bone or tendon Hypersensitivity to bovine collagen
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiannis Monovoukas, PhD
Organizational Affiliation
TEI
Official's Role
Study Chair
Facility Information:
Facility Name
HyperbaRXs
City
Cumming
State/Province
Georgia
ZIP/Postal Code
30041
Country
United States
Facility Name
Covenant Medical Center
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Professional Hospital
City
Guaynabo
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Dr. Pila Metropolitan Hospital Wound Healing Center
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Caribbean Clinical Trials
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Doctors' Center Hospital of San Juan
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Wound and Ulcer Care Clinic of San Juan
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Wilma N. Vazquez Hospital
City
Vega Baja
ZIP/Postal Code
00694
Country
Puerto Rico

12. IPD Sharing Statement

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A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

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