NCT06838234

Brief Summary

The aim of this study is to Help clinician modification of treatment through assess the validity and reliability of Arabic version of 17 items QOL questionnaire in patients with chronic wound. It translated to many languages but not present in form of arabic version.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 9, 2025

Last Update Submit

February 18, 2025

Conditions

Keywords

Validity and reliability. .Arabic version QOL questionnairechronic wound

Outcome Measures

Primary Outcomes (3)

  • Body subscale

    Body subscale include items (1-5). (My wound hurt, my wound had a bad smell , there was a distributing discharge from wound, the wound has affected my sleep , the treatment of the wound has been burden to me) score range from 0 to 4 , score 0 indicate better and score 4 indicate worser

    outcome measure will be applied after one month of wound injury

  • Psyche subscale

    Psyche subscale include items (6\_10), score range from 0 to 4 , score 0 indicate better and score 4 indicate worser ( The wound has made me unhappy, I have felt frustrated because the wound is taking so long to heal, I have worried about my wound,I have afraid of the wound getting worse or of new wounds appearing,I have afraid of knocking the wound

    outcome measure will be applied after one month of wound injury

  • Day life subscale

    Day life subscale include items (11-16)I have been a trouble moving about because of the wound, climbing stairs has been difficult because of the wound, I have had a trouble with day to day activities , The wound has limited my leisure activities , The wound has forced me to limit activities with others, I have felt dependant on help from other. score range from 0 to 4 , score 0 indicate better and score 4 indicate worser

    outcome measure will be applied after one month of wound injury

Study Arms (1)

1 group suffering from chronic wound

Patients who have chronic wound will answer the items of the questionnaire

Other: Arabic version QOL questionnaire

Interventions

Arabic version QOL questionnaire The Wound-QoL is a wound-specific questionnaire containing 17 items from which one can derive three subscales and . The items 1-5, 6-10, and 11-16 belong to the subscale body, psyche, and everyday life, respectively

1 group suffering from chronic wound

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study includes 100 patients of both sexes with chronic wound with ages between 40-60 years. Recruited from outpatient clinic of Faculty of Physical Therapy Cairo University and El matarya hospital Patients with chronic wound at least one month ( Venus and arterial ulcer , diabetic foot, burn , Post operative wound healing defect)

You may qualify if:

  • Patients who suffering from chronic wound at least 1 month prior to study enrollment,
  • Patients aged between 40-60 years .Provision of written informed consent. .All participants will be able to read and write in Arabic language. .All participants can understand items of the questionnaire.

You may not qualify if:

  • Patients who had mental illnesses
  • Patients who were unable to fill in the questionnaire independently or answered the questions orally .Patient with communication, vision, hearing disorders. .Patient who doesn't fill the questionnaire till the end.
  • Patient who were isolated due to infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Study Officials

  • Karim I Abo Khalil safaan

    Assistant Professor at surgery and burn Department , Faculty of Physical Therapy Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist at 23rd of July hospital,M.SC physiotherapy, Cairo university

Study Record Dates

First Submitted

February 9, 2025

First Posted

February 20, 2025

Study Start

August 2, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

February 20, 2025

Record last verified: 2025-02

Locations