Evaluation of Compression Therapy in Patients With Mild to Moderate PAD or Diabetes Mellitus

University Hospital Erlangen

Status: Completed

Conditions: Leg Edema; Diabetes Mellitus; Peripheral Arterial Disease

Treatments: Device: Compression Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03384758

Perfusion under Compression

Details and patient eligibility

About

Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.

Full description

Aim of this prospective clinical study is the Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus. The microcirculation should be assessed by a combination of laserdoppler flowmetry and white light tissue spectrometry (O2C Device, Parameters sO2, Flow, rHb). By this, it is possible to detect the influence of the compression therapy on the skin microcirculation.

Therefore, three study arms should be investigated, all patients clinically suffering under leg edema: healthy volunteers, patients with mild to moderate PAD and diabetics. All patients are recieveing compression therapy (Compression stockings class I for three hours, after a short break compression stockings class II for 3 hours) under Perfusion assessment control (O2C device).

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Study-Arm PAD:

• leg edema
• symptomatic PAD (Fontaine stage II)
• no palpable foot pulses
• ABI <0.9 and >0.6, absolute ankle pressure > 60mmHg

Study-Arm Diabetes:

• leg edema
• Diabetes mellitus Typ 2 (history of longer than 2 years)
• palpable foot pulses
• Pallaesthesie >6
• Wagner Score 0

Exclusion criteria

Study-Arm PAD:

• Critical limb ischemia
• ABI < 0.6
• simoultaneous Diabetes Mellitus

Study-Arm Diabetes:

• Wagner Score >0
• Pallasthesie <6

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

94 participants in 3 patient groups, including a placebo group

mild to moderate PAD

Active Comparator group

Treatment:

Device: Compression Therapy

Diabetes mellitus

Active Comparator group

Treatment:

Device: Compression Therapy

Healthy volunteers

Placebo Comparator group

Treatment:

Device: Compression Therapy