GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers

A Multicenter, Randomized, Single-Blind Study Comparing the Efficacy of GrafixPRIME® to Active Comparator for the Treatment of Chronic Diabetic Foot Ulcers

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02675855

Enrollment

Registered

2016-02-05

Start date

2016-01-31

Completion date

2017-07-31

Last updated

2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Ulcer, Diabetic

Keywords

Grafix

Brief summary

The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.

Interventions

OTHERGrafixPRIME®

Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

PROCEDUREDressing Application

Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.

DEVICEOff-loading (walking boot)

Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Type 1 or Type 2 Diabetes * Chronic ulcer (present for ≥4 weeks, but not more than 52 weeks) * Index ulcer located below the malleoli on the plantar or dorsal surface of the foot * Index ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone or joint capsule * Adequate circulation to the foot (documented by ABI or TBI)

Exclusion criteria

* Gangrene present on affected foot * Index ulcer is over a Charcot deformity * Patient is receiving dialysis * Patient has 2 or more previous amputations * Patient has HbA1c \>12% or random blood sugar \>450 mg/dl * Chronic oral steroid use * Use of IV corticosteroid, immunosuppressive, or cytotoxic agents * IV antibiotics * Another ulcer within 5cm of the Index ulcer * Cellulitis, evidence of infection, or osteomyelitis

Design outcomes

Primary

Measure	Time frame
Complete closure of index wound	Up to Day 56

Secondary

Measure	Time frame
Time to wound closure	Up to Day 56
Proportion of patients that achieve a 50% reduction or greater in wound size	Day 28
Number of product applications	Up to Day 56
Number of Adverse Events	Up to Day 56
Number of patients with worsening of wound by ≥50% increase in size	Up to Day 56

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026