Varithena view study.

Varithena

VIEW-VLU clinical study

The prospective, multicenter, and open label 12-month phase 4 registry confirmed Varithena’s impact on venous leg ulcers.

The VIEW-VLU study evaluated venous leg ulcer healing rate, recurrence rate, and patient reported outcomes for Varithena. 


Key study results

In a challenging population, treatment of venous leg ulcers with Varithena showed rapid initial wound healing and sustained improvements in quality of life and pain.1

Initial closure

53.8% ulcers healed by 12 weeks.

12-Month closure

75% ulcers healed by 1 year.

 Symptom improvement

Graph showing a 64% improvement in pain scores, illustrating the effectiveness of Varithena treatment based on clinical evidence.

Patient characteristics


  • Obese to extremely obese (36.3  ± 10.2 BMI)    
  • Chronic ulcers (8 months ± 12 months at first encounter)
  • Severity of ulcers:
    • 26.3% circumferential wound
    • 12.5% hospitalization for target ulcer
    • 27.5% of ulcers were previously treated

Study methods


  • Total injection sites 2.1 ± 1.6
  • Varithena volume injected (mL): 
    • 3.9 ±  5.7 above the knee
    • 9.4 ±  4.5 below the knee
  • Follow up visits at 1 week, 12 weeks, and 12 months; phone calls at 6 months post-treatment and 3 months post-wound closure

VIEW-VLU did not exclude patients based on wound size or wound age, leading to a challenging patient population

See how Varithena microfoam impacts a venous leg ulcer

Hear Principal Investigator Dr. Michael Shao discuss the unique method and distinctive results of the VIEW-VLU study

References

1. Shao MY, Harlin S, Chan B, Santangelo K, Fukaya E, Stoughton J, Kolluri R; VIEW-VLU Investigators. VIEW-VLU observational study of the effect of Varithena on wound healing in the treatment of venous leg ulcers. J VascSurg Venous LymphatDisord. 2023 Mar 25:S2213-333X(23)00131-2. doi: 10.1016/j.jvsv.2023.01.011. Epub ahead of print. PMID: 36972751