Evaluation of Compression Therapy in Patients With Mild to Moderate PAD or Diabetes Mellitus
Evaluation of the Effect of Compression Therapy on the Microcirculation in Patients With Leg Edema and Mild to Moderate PAD or Diabetes Mellitus.
1 other identifier
interventional
94
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2017
CompletedFirst Posted
Study publicly available on registry
December 27, 2017
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 8, 2020
May 1, 2020
9 months
December 12, 2017
May 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
12 Months
sO2
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter sO2
12 Months
Flow
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter Flow
12 Months
rHb
The Perfusion Situation should be recorded on the Level of Microcirculation by the Parameter rHb
12 Months
Study Arms (3)
mild to moderate PAD
ACTIVE COMPARATORDiabetes mellitus
ACTIVE COMPARATORHealthy volunteers
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Study-Arm PAD:
- Critical limb ischemia
- ABI \< 0.6
- simoultaneous Diabetes Mellitus
- Study-Arm Diabetes:
- Wagner Score \>0
- Pallasthesie \<6
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Erlangen, Vascular Surgery
Erlangen, 91054, Germany
Related Publications (1)
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.
PMID: 32503811DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator PD Dr. med. Ulrich Rother
Study Record Dates
First Submitted
December 12, 2017
First Posted
December 27, 2017
Study Start
May 1, 2018
Primary Completion
February 1, 2019
Study Completion
March 1, 2019
Last Updated
May 8, 2020
Record last verified: 2020-05