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

University Hospital Erlangen94 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease Diabetes Mellitus Leg Edema

Interventions

Compression TherapyDEVICE

Therapy of the leg edema with compression stockings class I for three hours, after a short break with compression stocking class II for again three hours.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Erlangen, Vascular Surgery

Erlangen, Germany

Outcomes

Primary Outcomes

Number of participants with treatment-related adverse events as assessed by questionnaire

The Adverse Events are defined in the questionnaire as: Abort of the Therapy, Pressure marks, Quantification of the wearing comfort (Points 1-10), subjective reduction of the leg edema (Points 1-10)

Time frame: 12 Months

sO2

The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2

Time frame: 12 Months

Flow

The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow

Time frame: 12 Months

rHb

The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb

Time frame: 12 Months

Data from ClinicalTrials.gov

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