Status:
COMPLETED
Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Brief Summary
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
Detailed Description
This 12 month, multicenter, open-label registry is designed to collect treatment and outcome data related to participants treated with Varithena for great saphenous vein (GSV) system and/or anterior a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 28 2020
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03257254
Start Date
September 29 2017
End Date
September 28 2020
Last Update
December 14 2021
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Palo Alto, California, United States, 94304
2
University of California Davis Health
Sacramento, California, United States, 95817
3
The Vascular Experts
Darien, Connecticut, United States, 06820
4
Pines Clinical Research
Aventura, Florida, United States, 33180