Safety of the Medical Adaptive Compression System circaid® juxtalite® in patients with CVI (C3-C6) and additionally existing diabetic foot syndrome and PAD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036241

Enrollment

Registered

2025-03-04

Start date

2025-11-26

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I87.2

Interventions

Group 1: Application of the medical adaptive compression system circaid® juxtalite® to one leg for three consecutive days in ascending pressure ranges (20-30, 30-40, 40-50mmHg), the day before the fir

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Chronic venous insufficiency (CEAP C3-C6) with existing edema on the lower leg on the leg included in the study - Diabetes mellitus (at least 2 years and at least one medication) with DFS on the leg included in the study - Evidence of atherosclerosis in the arteries of the leg included in the study - ABI = 0.5 on the leg included in the study, pole test if ABI >1.3 (suspected medial sclerosis) - Patient must be able to be mobilized to the edge of the bed for the measurements and remain there for 15 minutes

Exclusion criteria

Exclusion criteria: - Decompensated heart failure (NYHA III-IV) - Ankle arterial pressure 38 °C - Septic phlebitis - Phlegmasia coerulea dolens - Pre-existing critical limb ischemia of the included leg, determined by clinical ischemia diagnostics - Compression therapy in the 24 h prior to the first measurement - Crural bypass on the included leg - Severe cognitive impairment - Existing pregnancy

Design outcomes

Primary

Measure	Time frame
Safety of the medical adaptive compression system application in terms of the absence of critical ischemia under compression therapy (Pratt clinical ischemia diagnosis) on days 1, 2, 3, and 4, in the morning and again after 5–6 hours	—

Secondary

Measure	Time frame
• Safety of the medical adaptive compression system application by evaluating the pulse oscillography risetime on the big toe on days 1, 2, 3, and 4, in the morning and again after 5-6 hours • Change in the circumference of the lower leg at the point with the greatest circumference (edema severity) on days 1,2,3,4 in the morning and again after 5-6 hours (at the same point) • Change in the circumference of the ankle and foot at the point with the greatest circumference on days 1,2,3,4 in the morning and again after 5-6 hours (at the same points) • User satisfaction (handling/practicality of the medical adaptive compression system) using a school grading system when putting on and taking off the test product on days 2,3,4 • Patient comfort using a school grading system on days 2,3,4 after taking off the test product	—

Measure

Time frame

• Safety of the medical adaptive compression system application by evaluating the pulse oscillography risetime on the big toe on days 1, 2, 3, and 4, in the morning and again after 5-6 hours • Change in the circumference of the lower leg at the point with the greatest circumference (edema severity) on days 1,2,3,4 in the morning and again after 5-6 hours (at the same point) • Change in the circumference of the ankle and foot at the point with the greatest circumference on days 1,2,3,4 in the morning and again after 5-6 hours (at the same points) • User satisfaction (handling/practicality of the medical adaptive compression system) using a school grading system when putting on and taking off the test product on days 2,3,4 • Patient comfort using a school grading system on days 2,3,4 after taking off the test product

—

Countries

Germany

Contacts

Public ContactAlexander Hyhlik-Dürr

Universitätsklinikum Augsburg

alexander.hyhlik-duerr@uk-augsburg.de+49 821 400 2655

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026