Clinical evidence

GRAFIX Cryopreserved placental membrane: Prospective study shows improved closure of chronic venous leg ulcers when added to standard of care27


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

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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.