GRAFIX◊ Cryopreserved Placental Membrane: Retrospective analysis results mirror RCT closure rates in diabetic foot ulcers (DFUs)12
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 closed12-14