Status:
ENROLLING_BY_INVITATION
Evaluation of Lymphatic Response to Physiotherapy in Patients With Swelling Associated With Superficial Venous Disease
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Tactile Medical
Conditions:
Chronic Venous Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study seeks to demonstrate the effect of advanced pneumatic compression in treatment naïve patients with CEAP C3 and C4 chronic venous disease. The main questions it aims to answer are: * Does l...
Eligibility Criteria
Inclusion
- Participant \>18 years of age
- Participant with an objective diagnosis of CEAP Class 3 or 4 superficial venous disease (superficial reflux time \>0.5 sec), with venous edema (revised VCSS score of 2 or 3 for edema).
- Participant must provide informed consent
- Participant is willing and able to fulfill study timeline
- Participant is a candidate for APCD treatment per the FTP indications
- Lymphatic dysfunction is observed, using NIRF-LI, in affected limb.
Exclusion
- History of pelvic or lower extremity cancers
- Systemic organ failure including heart failure
- BMI \>35
- Previous endovascular or open vascular interventions
- Patients with known, or family history of, primary lymphedema
- Prior use of advanced pneumatic compression device, or complete decongestive therapy (CDT) on the lower extremities
- Peripheral arterial disease with ABI \<0.8
- Participants with deep venous obstruction
- Skin disease not related to CVD
- Participants with iodine allergies including patients with shellfish allergy who may be allergic to iodine that may be in the ICG formulation
- Females who are pregnant or breastfeeding
- Females with the intent of becoming pregnant within 30 days after participation in final imaging session
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT07165340
Start Date
September 1 2025
End Date
August 1 2026
Last Update
September 16 2025
Active Locations (1)
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1
University of Texas Health Science Center at Houston/UTPhysicians
Houston, Texas, United States, 77030