N/A
N=76
Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
Venous Leg Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03257254 ↗Enrolled (actual)
76
Serious AEs
7.9%
Results posted
Dec 2021
Primary outcome: Primary: Change From Baseline in Wound Perimeter — 29.36; 43.64 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Varithena (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Wound Perimeter |
29.36; 43.64 | — |
| PRIMARY Number of Wound Closure at 12 Weeks |
43 | — |
| PRIMARY Time to Wound Closure |
89 | — |
| SECONDARY Change in Pain |
-1.4; -2.5 | — |
| SECONDARY Change on EQ-5D-5L Quality of Life Assessment |
0.066; 0.072 | — |
| SECONDARY Change in VCSS |
-5.8; -10.0 | — |
| SECONDARY Number of Wounds Remaining Closed at 3 Months Post-wound Closure Date |
47 | — |
| SECONDARY Number of Wound Recurrences |
7 | — |
| SECONDARY Number of Ulcer Free Days |
240.5 | — |
Summary
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
Eligibility Criteria
Inclusion Criteria
- Men and women; age ≥18
- Investigator has selected Varithena® to treat participants classified C6 with chronic (≥3 months) VLU resulting from GSV and/or AASV incompetence
- Wound can be visualized in one plane to allow for image collection of the entire wound in one photograph, or if wound is circumferential, participant must be able to capture the entire wound using multiple photographs taken from directly above the wound (straight on)
- Reflux >500 milliseconds (ms) on duplex ultrasound
- Willing and able to collect wound photographs and data using an application installed on a tablet
- Willing and able to return for scheduled follow-up and wound care visits
- Ability to comprehend and sign informed consent form (ICF) and complete questionnaires
Exclusion Criteria
- Contraindications to Varithena® 1% in accordance with the FPI
- Any serious concomitant disease, per physician's discretion, that confounds wound healing, including malignant changes of wound
- Concomitant heat ablation, or heat ablation of index leg within 6 weeks prior to treatment with Varithena®
- Significant arterial disease or ankle-brachial pressure index (ABPI) ≤0.8
- In the opinion of Investigator, wound would close within 12 weeks without additional treatment
Data sourced from ClinicalTrials.gov (NCT03257254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.