Table 4.
Summary of DFU prospective clinical studies with commercial placental products
| Biovance (Celgene) | EpiFix (MiMedx) | Grafix (Osiris) | |||
|---|---|---|---|---|---|
| Product description | Decellularized, dehydrated cross-linked amnion | Dehydrated devitalized amnion and chorion (containing trophoblast) | Cryopreserved viable amnion | ||
| Study type | Open label | Randomized, controlled, nonblinded, single center | Randomized, controlled, nonblinded, single center | Randomized, controlled, nonblinded, multicenter | Randomized, controlled, single blinded, multicenter |
| No. of patients | 14 (9 evaluated) | 13 treatment/12 SOCa | 40 (20 per arm) weekly/biweekly | 20 treatment/20 SOCb | 50 treatment/47 SOCc |
| No. of centers (geographic locations) | Not reported | 1 (VA) | 1 (VA) | 3 (VA) | 20 (TX, NJ, RI, GA, OH, MO, FL, CA, AZ, NY, PA, AL, LA, NC) |
| Wound size (mean, cm2) | Not reported | 2.6 treatment/3.4 SOC | 2.0 treatment/2.4 SOC | 2.7 treatment/3.3 SOC | 3.41 treatment/3.93 SOC |
| Closure rate | 55.5% (week 12) | 92% treatment/8% SOC (week 6) | 95% treatment/70% SOC (week 6) | 95% treatment/30% SOC (week 6) | 62% treatment/21% SOC (week 12) |
| Mean number of treatments | 2.3 | Not reported | 2.3 treatment/2.4 SOC | 2.15 treatment/not specified SOC | 6 treatment/12 SOC |
| References | 66 | 67 | 70 | 71 | 72 (results of crossover and follow-up are included in this publication) |
| 68 (results of crossover phase reported) | |||||
| 69 (follow-up results are reported) | |||||
| Standard of care | Not specified | Debridement, moist dressing, compression dressing, daily wound dressing changes performed by patient at home, off-loading | Weekly debridement, adaptic (nonadherent dressing) followed by a moisture-retentive dressing Nugel and a compressive padded dressing Dynaflex, weekly wound dressing change, off-loadingd | Weekly debridement if necessary, moist dressing, compression dressing, daily wound dressing changes performed by patient at home (collagen alginate and gauze), off-loading | Weekly debridement, adaptic (nonadherent dressing) with saline moist gauze or Allevyn, off-loading |
a
Eleven SOC patients were enrolled in the open-label crossover phase and showed 91.2% complete closure at week 12.
b
This study also had a group (n=20) treated with Apligraf.
c
Twenty-six SOC patients were enrolled in the open-label crossover phase and showed 67.8% probability of wound closure with a mean time to closure of 42 days.
d
EpiFix weekly or biweekly was applied with SOC.
SOC, standard of care.