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Evaluation of the effect of Compression Stocking containing Natural Product in the treatment of Ulcers and Varicose Veins

Clinical study randomized, blind, controlled of effect of compression Stocking containing nanoencapsulated Flavonoid in the treatment of chronic venous Insufficiency

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5n9cmf
Enrollment
Unknown
Registered
2018-08-01
Start date
2018-07-17
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic venous insufficiency

Interventions

Experimental group: 10 patients will use compression stockings containing nanoencapsulated hesperetin and placebo for oral use (every 12 hours)
Control group: 10 patients will use conventional compression stocking and venoactive drug (hesperidin 450 mg + diosmin 50 mg) for oral use (every 12 hours)
Placebo group: 10 patients will use conventional compression stocking and placebo for oral use (every 12 hours). All patients should wear the received stockings immediately after waking up and remain
Drug
Other
H01.603

Sponsors

Universidade Federal de Sergipe
Lead Sponsor
Universidade Federal de Sergipe
Collaborator

Eligibility

Age
30 Years to 59 Years

Inclusion criteria

Inclusion criteria: Volunteers with varicose veins, varicose veins plus edema, hyperpigmentation, lipodermatosclerosis, healed venous ulcer or active ulcer; age between 30 and 59 years; both genders; similar impairment of the saphenous vein

Exclusion criteria

Exclusion criteria: Volunteers with telangiectasias; cognitive alterations; diabetics; neuropaths; with erysipelas; lymphangitis; deep vein thrombosis; ulcer of non-venous origin; psychiatric disorders; demence; without speaking or understanding the Portuguese language; use of antibiotic or venoactive drugs in the last six months prior to the start of the research; sclerotherapy of lower limbs; surgical procedure; use of Unna boot, multi-layer dressing or dressing with topical medicine; children; morbidly obese; pregnant women; infants; patients at risk of pregnancy

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1: Healing of ulcers in the six-month period comprised in the study, verified by reduction of the size of the wound using the software Image J. The lesions with reduction greater than 70% of their total extension will be considered healed.;Expected Outcome 2: Improvement in patients' quality of life after six months of treatment. This outcome will be measured by the volunteers' responses to the Aberdeen questionnaire and the Wilcoxon test will be performed to check whether the patients achieved (p <0.05) or did not improve satisfactorily.

Secondary

MeasureTime frame
Reduction of pain reported by the volunteer in the EVA questionnaire. This outcome will be measured according to the patients' responses using the Wilcoxon test to check whether the patients achieved (p <0.05) or did not improve satisfactorily.

Countries

Brazil

Contacts

Public ContactPaula Menezes

Universidade Federal de Sergipe

paula.dp.menezes@gmail.com+55-079-99152-9392

Outcome results

None listed

Source: REBEC (via WHO ICTRP)