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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Diabetes Mellitus; Leg Edema
• Interventions: Device: Compression Therapy

• Registration Number: NCT03384758
• Lead Sponsor: University Hospital Erlangen

Brief Summary

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-27
• Study Start: 2018-05-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-03-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mild to moderate PAD	Compression Therapy	-
Diabetes mellitus	Compression Therapy	-
Healthy volunteers	Compression Therapy	-

Primary Outcome Measures

Name	Time	Method
Flow	12 Months	The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow
Number of participants with treatment-related adverse events as assessed by questionnaire	12 Months	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)
rHb	12 Months	The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb
sO2	12 Months	The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2

Trial Locations

Locations (1)

University of Erlangen, Vascular Surgery; 🇩🇪 Erlangen, Germany