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Clinical Trials in Italy / NCT06938048
Enrolling by invitation Not applicable

COMPARISON OF BANDAGE IN HAND EDEMA

NCT06938048 · tracked via the Priya Life Science Italy tracker
Sponsor
Regione del Veneto - AULSS n. 7 Pedemontana
Phase
Not applicable
Started
2024-09-06
Last updated
2025-04-22

Condition(s) studied

Edema

Investigational drug(s) / intervention(s)

short stretch bendage (Lohmann e Raucher)high stretch bandage (Coban)

short stretch bendage (Lohmann e Raucher): extensibility between 10% to 100% of the lenght

high stretch bandage (Coban): extensibility above 100% of the lenght

Study summary

The aim of this clinical trial is to compare the effectiveness of high and short stretch bandages in hand edema treatment of adult patients with affected hand volume superior of at least 5% compared to the contralateral hand. The main question to be answered by this study is: which bandage is more effective in reducing edema?

Endpoint 1: hand volume, measured by immersion volumetry (Valgrado method). Endpoint 2: ROM (range of motion) of the fingers and wrist, measured by goniometry.

Endpoint 3: Results of a semi-structured interview on participants subjective perception of hand function and esthetics, ADL performance and quality of life.

This study includes 2 groups (arms); each participantreceives both types of bandages but in a different temporal order depending on group membership:

* Arm A: short stretch bandage applied as the first treatment.
* Arm B: high stretch bandage applied as first treatment. Patients will be randomized 1:1 using the RedCap Software.

The entire study will take place over 3 consecutive days. On each of these days, participants are examined (hand volume, finger and wrist ROM), receive the bandage (the type of bandage depends on the participant group), undergo physiotherapy treatment and then practice specific hand mobilization exercises at home.

At the end of the study, the data on hand volume and mobility of the hand and wrist will be analyzed to determine which type of bandage, high-stretch or low-stretch one, is most effective in reducing hand volume (and therefore hand edema) and mobility of the hand and wrist.

In addition, data collected using the semi-structured interview will be analyzed to examine patients subjective perceptions of hand function and esthetics, ADL performance and quality of life.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Study Population A total of 45 patients will be recruited for this study, according to the following inclusion and exclusion criteria. Inclusion Criteria * Presence of hand edema, with the affected hand showing a volume at least 5% greater than the contralateral hand. Hand volume is measured using the Valgrado immersion volumetry method. * Edema of the following etiologies: * Traumatic (injury to the hand or upper limb resulting in edema of the hand or fingers) * Surgical * Algodystrophic * Rheumatologic * Secondary to immobility Exclusion Criteria * Lacerations or cut injuries to the forearm, due to the potential compromise of lymphatic drainage pathways from the hand. * Edema of etiologies other than those specified in the inclusion criteria. Specifically, edema due to infection or structural and/or functional impairment of the lymphatic system-of any nature, including iatrogenic-is excluded. * Pathologies involving the peripheral nervous system of the upper limb (e.g., nerve injuries with resulting paralysis). * Contraindications to active mobilization of the wrist and finger joints (metacarpophalangeal and interphalangeal joints).

Primary outcome measure(s)

  • Hand volume — Hand volume will be measured 3 times, from enrollment to 48 hours after: T0 (first assessment), T1 (24 hours after first bandage application), T2 (24 hours after second bandage application).
    Hand volume will be measured using immersion volumetry, according to the Valgrado method.

Trial sites (1)

FacilityCityRegionStatus
ULSS 7 Pedemontana Bassano Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06938048 on ClinicalTrials.gov ↗ ← All trials in Italy