CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 226 enrolled
Drug / intervention
PriMatrix Dermal Repair Scaffold +2 moredevice
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Age ≥18 years
  • ✓Type I or Type II diabetes mellitus with HbA1c ≤12% within 3 months prior to screening
  • ✓At least one diabetic foot ulcer of partial or full thickness, without capsule/tendon/bone exposure, and without tunneling, undermining, or sinus tracts
  • ✓Ulcer located on foot or ankle (no portion above top of malleolus)
Key exclusion· 10
  • ✕Suspected or confirmed gangrene, ulcer infection of study ulcer, or receiving systemic antibiotics for such
  • ✕Suspected or confirmed osteomyelitis of the foot with the study ulcer
  • ✕History of hypersensitivity to bovine collagen
  • ✕Participated in another clinical trial with device or investigational drug/treatment within 28 days of randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03010319
NCT03010319N/ACompleted
CompareCT.gov

Prospective, Multi-center, Randomized, Controlled Trial Evaluating the Use of PriMatrix Dermal Repair Scaffold for the Management of Diabetic Foot Ulcers

Integra LifeSciences Corporation·interventional·Posted Jan 5, 2017·Updated Apr 29, 2022

In Brief

A clinical study evaluating PriMatrix Dermal Repair Scaffold, Secondary Dressings, and 1 other intervention for Diabetic Foot Ulcer. Completed, enrolled 226 participants across 17 sites.

Detailed Summary

The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment. Half of patients will be treated using PriMatrix while the other half will receive Standard of Care treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Foot Ulcer
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 5, 2017
Enrollment StartJan 1, 2017
Primary CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.5 years ago

Interventions

PriMatrix Dermal Repair Scaffolddevice

Application of PriMatrix to ulcer

Secondary Dressingsdevice

Dressings to ensure moist wound environment

Offloading devicedevice

Offloading device to decrease pressure to wound area