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

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ClinicalTrials.gov Identifier: NCT03384758
Recruitment Status : Completed
First Posted : December 27, 2017
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Ulrich Rother, University Hospital Erlangen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Diabetes Mellitus Leg Edema Device: Compression Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: mild to moderate PAD Device: 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.
Active Comparator: Diabetes mellitus Device: 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.
Placebo Comparator: Healthy volunteers Device: 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.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384758


Locations
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Germany
University of Erlangen, Vascular Surgery
Erlangen, Germany, 91054
Sponsors and Collaborators
University Hospital Erlangen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ulrich Rother, Principal investigator PD Dr. med. Ulrich Rother, University Hospital Erlangen
ClinicalTrials.gov Identifier: NCT03384758    
Other Study ID Numbers: Perfusion under Compression
First Posted: December 27, 2017    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ulrich Rother, University Hospital Erlangen:
Compression therapy
Microcirculation
Diabetes mellitus
Peripheral Arterial Disease
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases