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Completed

NCT Number: NCT02838251

Effects of Compression in Mixed Ulcers

About 15% to 30% of patients with venous leg ulcers have a peripheral arterial disease (PAD) associated. The compression band is still a controversial issue in this context. It allows the reduction of venous hypertension and edema, but it could potentially degrade the arterial infusion of high levels of compression. The French High Authority for Health (HAS) defines mixed ulcers by IPS between 0.5 and 0.9. Investigators distinguish mixed ulcers blood predominance for IPS between 0.5 and 0.7; and mixed ulcers predominantly venous blood with moderate involvement for IPS values between 0.7 and 0.9.

Several studies have shown that IPS> 0.8 allowed a high compression, between 30 and 40 mmHg. In the case of mixed ulcers with IPS between 0.6 and 0.8, the HAS recommends using a lighter compression, bit by elastic bands (exercising low power compression at rest) under medical supervision, informing the patient to remove the bandage if pain or aggravation. It is therefore necessary to adapt the compression therapy in case of venous ulcers associated with arterial disease by providing a lower compression 30 mmHg short stretch. For HAS, IPS <0.6 against indicates compression.

A recent study showed that compression bit elastic bands could not only improve venous return, but it would also increase the distal arterial flow in a patient population with mixed ulcers. In this study, 25 patients had between IPS 0.5 and 0.8; or for certain patients below the threshold of 0.6 indicates that against a compression according to HAS. To our knowledge this is the only study that has examined the effect of compression on blood perfusion.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

About this study

Objectives:

  • Principal: Study the distal arterial infusion in a patient population with mixed ulcers under compression leg with little elastic bands
  • Secondary: To evaluate the safety of the little compression elastic band in a mixed population of patients with leg ulcers

Methodology :

  • Study non-interventional prospective single-center that evaluates professional practice from 25 patients with mixed leg ulcers and followed in the vascular medicine department of St. Joseph Hospital Group Paris.
  • Applying a bit compression elastic bandages to a pressure level between 30 and 40mmHg.
  • Anonymous data reports on the grid standardized collection, by a numbering system from 1 to 30 and then captured on a computer file
  • Age, risk factors and cardiovascular history of the patients,
  • Age, ulcer description
  • Palpation of pulse
  • morphological vascular profile of patients with arterial and venous Doppler dating less than a year,
  • Series following data before installation, 10 minutes after application and 24 hours after installation of the inelastic compression:

o Evaluation of tolerance:

  • measurement of pain numeric scale (NS)
  • description of the skin condition of the leg by a dermatologist, seeking signs of suffering skin after application of compression: possible appearance of erythema, cyanosis, purpura. A search particularly in areas of bony prominences and the banks of the ulcer.

o distal arterial pressures of the compression carrier leg:

  • IPS (systolic pressure index): ankle and arm pressures will be measured with a cuff and a continuous Doppler. GPI is calculated by dividing the lowest pressure at the ankle (at the dorsalis pedis or posterior tibial artery) by the humeral pressure.
  • Transcutaneous Oxygen Pressure (TcPO2) o Measuring pressure exerted by low elastic bandages by Kikuhime® system.

In case of bad tolerance of compression at any time after installation, the compression will be removed and the study stopped for the patient in question. Poor tolerance is defined by an increase in pain than or equal to 2 points on the digital scale.

expected benefits for patients:

  • Demonstration of good tolerance, defined as no worsening of the skin condition and the lack of increase in pain associated with inelastic compression.
  • Demonstration of no worsening of arterial infusion by inelastic compression.
  • Evidence of improved distal arterial hemodynamics (increased IPS and tcpO2) with a little elastic compression, which validate the results of the only study ever conducted on the subject.

Who can participate

Healthy volunteers accepted: No

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

The mixed origin of the ulcer is defined by a venous disease (reflux in the superficial veins and / or deep) and a moderate arterial disease, defined by:

Inclusion criteria

  • A IPS 0.5 and 0.9, with a systolic pressure at the ankle> 70 mmHg
  • A big toe pressure index (IPGO) <0.7, with a systolic pressure of the big toe (PGO)> 50 mmHg

Exclusion criteria

  • Topics aged under 18,
  • A normal IPS that is to say between 0.9 and 1.3, a critical ischemia (defined as ankle pressure <70 mmHg and / or systolic pressure of the big toe <50 mmHg)
  • Presence of peripheral neuropathy,
  • Presence of heart failure,
  • Refusal to participate in the study or to sign the consent,
  • Impaired cognitive function not to participate in a clinical study.

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Assessment of change of pain numeric scale

    Time frame: Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam

Secondary outcomes

  1. Assessment of change of distal arterial pressures of the compression carrier leg

    Time frame: Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam

  2. Assessment of change of IPS (systolic pressure index) ankle pressures

    Time frame: Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam

  3. Assessment of change of pressure exerted by low elastic bandage

    Time frame: Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam

    Measuring pressure exerted by low elastic bandages by Kikuhime® system.

  4. Assessment of IPS (systolic pressure index) arm pressures

    Time frame: Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: ULCEREMIXTE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2016
Registry last updated
Jul 27, 2016

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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