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

Primary Purpose

Peripheral Arterial Disease, Diabetes Mellitus, Leg Edema

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Compression Therapy

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Compression therapy, Microcirculation, Diabetes mellitus, Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Erlangen, Vascular Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

mild to moderate PAD

Diabetes mellitus

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

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)

sO2

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

Flow

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

rHb

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03384758

First Posted

December 12, 2017

Last Updated

May 6, 2020

Sponsor

University Hospital Erlangen

1. Study Identification

Unique Protocol Identification Number

NCT03384758

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

February 1, 2019 (Actual)

Study Completion Date

March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Erlangen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease, Diabetes Mellitus, Leg Edema

Keywords

Compression therapy, Microcirculation, Diabetes mellitus, Peripheral Arterial Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mild to moderate PAD

Arm Type

Active Comparator

Arm Title

Diabetes mellitus

Arm Type

Active Comparator

Arm Title

Healthy volunteers

Arm Type

Placebo Comparator

Intervention Type

Device

Intervention Name(s)

Compression Therapy

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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

Title

sO2

Description

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

Time Frame

12 Months

Title

Flow

Description

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

Time Frame

12 Months

Title

rHb

Description

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

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

University of Erlangen, Vascular Surgery

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

32503811

Citation

Rother U, Grussler A, Griesbach C, Almasi-Sperling V, Lang W, Meyer A. Safety of medical compression stockings in patients with diabetes mellitus or peripheral arterial disease. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001316. doi: 10.1136/bmjdrc-2020-001316.

Results Reference

derived

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

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