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

Foot Ulcer, Diabetic Clinical Trial

Official title:

A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01270633
• Other study ID #: TEI-004
• Status: Terminated
• Phase: N/A
• First received: January 4, 2011
• Last updated: November 30, 2017
• Start date: December 2010
• Est. completion date: September 2017

Study information

• Verified date: November 2017
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Device:
• PriMatrix
Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy

Other:
• Standard of Care
Following sharp debridement, moist wound therapy

Locations

Country	Name	City	State
Puerto Rico	Professional Hospital	Guaynabo
Puerto Rico	Dr. Pila Metropolitan Hospital Wound Healing Center	Ponce
Puerto Rico	Caribbean Clinical Trials	San Juan
Puerto Rico	Doctors' Center Hospital of San Juan	San Juan
Puerto Rico	Wound and Ulcer Care Clinic of San Juan	San Juan
Puerto Rico	Wilma N. Vazquez Hospital	Vega Baja
United States	HyperbaRXs	Cumming	Georgia
United States	Covenant Medical Center	Saginaw	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of study ulcers healed	Percent of study ulcers healed at week 12 post-randomization	12 weeks post-randomization
Secondary	Cost of Treatment		12 weeks