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NCT Number: NCT03384758

Evaluation of Compression Therapy in Patients With 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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Leg Edema Metabolic Diseases Nutritional and Metabolic Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Erlangen, Vascular Surgery

Erlangen, 91054, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compression Therapy

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.

Primary outcomes

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

    Time frame: 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)

  2. sO2

    Time frame: 12 Months

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

  3. Flow

    Time frame: 12 Months

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

  4. rHb

    Time frame: 12 Months

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

Sponsors and collaborators

Lead sponsor

University Hospital Erlangen

Other

Registry information

Official study title

Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 27, 2017
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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