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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-03-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Peripheral Arterial Disease Diabetes Mellitus Leg Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mild to moderate PAD

Group Type ACTIVE_COMPARATOR

Compression Therapy

Intervention Type DEVICE

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.

Diabetes mellitus

Group Type ACTIVE_COMPARATOR

Compression Therapy

Intervention Type DEVICE

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.

Healthy volunteers

Group Type PLACEBO_COMPARATOR

Compression Therapy

Intervention Type DEVICE

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.

Interventions

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Compression Therapy

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.

Intervention Type DEVICE

Eligibility Criteria

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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