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

NCT01270633 | Terminated

• 1 other identifier: TEI-004
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 8

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.

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

• Percent of study ulcers healed

  Percent of study ulcers healed at week 12 post-randomization

  12 weeks post-randomization

Secondary Outcomes (1)

• Cost of Treatment

  12 weeks

Study Arms (2)

Treatment

OTHER

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

Device: PriMatrix

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

PriMatrix DEVICE

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

Treatment

Standard of Care OTHER

Following sharp debridement, moist wound therapy

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (8)

HyperbaRXs

Cumming, Georgia, 30041, United States

Location

Covenant Medical Center

Saginaw, Michigan, 48602, United States

Location

Caribbean Clinical Trials

San Juan, PR, 00918, Puerto Rico

Location

Professional Hospital

Guaynabo, 00717, Puerto Rico

Location

Dr. Pila Metropolitan Hospital Wound Healing Center

Ponce, 00717, Puerto Rico

Location

Doctors' Center Hospital of San Juan

San Juan, 00918, Puerto Rico

Location

Wound and Ulcer Care Clinic of San Juan

San Juan, 00918, Puerto Rico

Location

Wilma N. Vazquez Hospital

Vega Baja, 00694, Puerto Rico

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yiannis Monovoukas, PhD

  TEI

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-11

Locations

PR (6); US (2)