Clinical evidence

GRAFIX Cryopreserved Placental Membrane: Retrospective analysis results mirror RCT closure rates in diabetic foot ulcers (DFUs)30


Study overview

  • Retrospective, 58-center analysis of GRAFIX Membrane in the management of DFUs with Net Health’s WoundExpert electronic health record (EHR) database
  • Population: All patients who received GRAFIX Membrane in the management of DFUs over a 4-year period were evaluated* (360 patients, 441 wounds)

Patient demographics and wound characteristics

Multiple wounds in 4-year period Approx. 90%
> 6 wounds in 4-year period Approx. 50%
Wound size (mean) 5.1 cm2
Wound duration prior to treatment (mean) 102.4 days
Complex wounds with exposed bone, tendon or joint capsule 14.7%

Results

Complete wound closure (end of treatment)

59.4%

Time to wound closure (mean)

57.7 days

Number of grafts to close (mean)

5.2

Safety outcomes: Amputations

3%

Safety outcomes: Related infections

2%


Comparison between EHR real-world study and randomized, controlled trial

Study type Retrospective, multicenter Prospective, multicenter RCT
Wounds 350 97 (50 GRAFIX, 47 control)
Complex wounds Allowed Excluded
Complete wound closure at end of treatment 59.4% 62.0%

*Exclusion criteria: Wounds missing baseline/follow-up measurements or receiving other skin substitute treatment concurrent with GRAFIX Membrane.

†DFUs and wounds of other etiologies.

‡350 wounds out of the 441 wounds evaluated were analyzed for closure and closure-related outcomes. Wounds ≤ 0.25 cm2 were not included in the closure analysis. 0.25 cm2 was chosen as a minimum size for closure analysis since in previous publications of WoundExpert database studies, wounds ≤0.25 cm2 were considered closed30-32