Effects of Compression in Mixed Ulcers

NCT02838251 | Completed DMC

• 1 other identifier: ULCERE MIXTE
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcer

Outcome Measures

Primary Outcomes (1)

• Assessment of change of pain numeric scale

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

Secondary Outcomes (4)

• Assessment of change of distal arterial pressures of the compression carrier leg

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

• Assessment of change of IPS (systolic pressure index) ankle pressures

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

• Assessment of change of pressure exerted by low elastic bandage

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

• Assessment of IPS (systolic pressure index) arm pressures

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

Interventions

No intervention OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects older than 18 years, suffering from an ulcer of mixed origin leg, and followed in the vascular medicine department of St. Joseph Hospital Group Paris.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

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

Location

MeSH Terms

Conditions

Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• STANSAL Audrey, MD

  Groupe Hospitalier Paris Saint-Joseph (FRANCE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 20, 2016
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 27, 2016

Record last verified: 2016-07

Locations

FR (1)