CLINICAL EVIDENCE

CLINICAL RESULTS

Single arm open label clinical study

Patients: 20 hard-to-heal wounds
Vergenix™FG application: single
Follow up: 4 weeks
Mean age: 63.6 years [36.1–85.3]

clinical_evidence_pie_1_002

Type of wound:

Neuropatic Ulcer
Post Trauma Wound
Venous Ulcer
Post Operative Wound

79% mean wound size reduction within 4 weeks after a single vergenix™FG application
By week 4:

Complete wound closure

45%

of patients

Good granulation tissue

90%

of patients

Reduction in pain level

50%

of patients

NO INFLAMMATORY RESPONSE, EDEMA OR ERYTHEMA
NO SERIOUS ADVERSE EVENTS

Source: Itay Wiser; Eran Tamir; Hanna Kaufman; Elad Keren; Shalom Avshalom; Doron Klein; Lior Heller; and Eyal Shapira.
A Novel Recombinant Human Collagen- based Flowable Matrix for Chronic Lower Limb Wound management: First Results of a Clinical Trial.
Wounds 2019 February 14

Post marketing surveillance1

Patients: 75 hard-to-heal wounds
Vergenix™FG application: single
Follow up: 16 weeks
Mean age: 65.7 years [17.7–92.2]

clinical_evidence_pie_2_002

Type of wound:

Post Operative Wound
Neuropatic Ulcer
Limb Venous
Post-Trauma Wounds
Not Reported
Pressure Ulcer

88% mean wound size reduction within 16 weeks after a single vergenix™FG application
By week 16, wound closure* observed in 72% of patients
Wound closure* by week 12:

Vergenix™FG

69%

of patients

Standard of care 2

24%

of patients

* >90% closure

Sources:
1. Post marketing surveillance – Data on file, CollPlant
2. Lavery LA et al. The efficacy and safety of Grafix for the treatment of chronic diabetic foot ulcers: results of a multicenter, controlled, randomized, blinded clinical trial.
Int Wound J. 2014 Oct;11(5):554-60.

Investigator initiated study

Investigating group: Diabetic Foot Section, Pisa University Hospital
Method:
24 patients undergoing diabetic foot surgical procedure, randomized into two Groups:
12 patients treated with standard of care (SOC) alone; 12 patients treated with Vergenix™FG on top of standard of care (SOC).
Vergenix™FG application: single
Follow up: weekly for 6 months or until wound closure

Patients treated with Vergenix™FG,
directly applied in operating room, in
addition to standard of care (SOC)

Patients treated with standard of
care (SOC) alone and left open to heal for
secondary intent

Healing rate significantly higher and healing time shorter in the group treated with Vergenix™FG on top of standard of care.

Among none-healed patients, wound area reduction was higher in Group A (78% vs 50% – χ2 10.9, p<0.02).
No adverse events or hypersensitivity reaction reported.

Source: Alberto PIAGGESI, Elisabetta IACOPI, Elisa BANCHELLINI, Nicola RIITANO, Letizia PIERUZZI, Chiara GORETTI, Diabetic Foot Section Pisa, University Hospital Poster presented at the Diabetic Foot Study Group 15th scientific meeting, 28-30 Sep 2018

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