GRAFIX◊ Cryopreserved Placental Membrane: Prospective study shows improved closure of chronic venous leg ulcers when added to standard of care9
Study overview
Prospective longitudinal crossover study of GRAFIX Membrane in the management of refractory chronic VLUs
Single-center, open-label, single-arm where each patient served as their own control
81 patients entered 12 week standard therapy phase*
21 patients with 30 VLUs failed to heal with 12 weeks of standard therapy
They crossed over to the 12 week GRAFIX Membrane treatment phase†
Results
VLUs that failed to close with 12 weeks of standard therapy made significantly greater progress toward closure when GRAFIX Membrane was added to the treatment:
Complete wound closure of chronic refractory VLUs:
53%
Mean 7.2 graft applications in
10.9 weeks
12 week follow-up phase:
no recurrence
Outcomes of standard therapy phase versus GRAFIX Membrane treatment phase in 21 crossover patients
| Standard therapy phase | GRAFIX treatment phase | P-Value | |
|---|---|---|---|
| Baseline wound size (mean) | 17.1 cm2 | 12.2 cm2 | |
| Complete wound closure | 0% | 53% | <0.001 |
| Wound area reduction (mean) | 29% | 79% | <0.001 |
*Standard therapy phase: Patients were treated for 12 weeks with SOC (included multi-layer compression).
†Inclusion criteria for the GRAFIX treatment phase included: 1) failed to heal in standard therapy phase; 2) venous insufficiency confirmed by duplex ultrasound; 3) no infection, ischemia or immunosuppression; and 4) radiofrequency ablation of the great saphenous vein for patients with evidence of superficial venous insufficiency. Radiofrequency ablation of the ipsilateral great saphenous vein was performed in 14 of the 21 patients at 4 weeks (mean) prior to entering the study.