Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT03363633
Eligibility Criteria:
Inclusion Criteria:
* • The subject must be \> 18 years of age, male or female
* Subject must be willing and able to wear compression stockings
* Subject must have refluxing perforating veins ≥ 3.0 mm in diameter at the calf level or distally in the affected leg.
* Subject presents with ulceration or other symptoms of venous stasis including:
rash, swelling, pain, bleeding, recurrent cellulitis
• The subject must sign a written informed consent, prior to randomization, using a form that is approved by the local Institutional Review Board.
Exclusion Criteria:
* • Pregnancy
* Known allergy to STS
* Refusal to wear compression stocking
* Untreated significant great or small saphenous reflux
* Disseminated malignancy or other terminal condition where subject is expected to live less than 6 months.
* Significant arterial disease (ABI \< .8)
* Buergers disease
* Acute superficial thrombophlebitis
* Phlebitis migrans
* Acute cellulitis
* Clinical evidence of active local or systemic infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03363633
Study Brief:
Protocol Section:
NCT03363633