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CompletedNCT06838234Updated Feb 20, 2025

Arabic Version QOL Questionnaire Chronic Wound

An observational study in Chronic Wound, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
40 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

The study will be cross sectional.participants: 100 patients according to sample size calculations suffering from chronic wound with age between 40-60 years. Using the minimum acceptable ICC of 0.75, expected ICC of 0.85, significance level 0.05, statistical power 80% and number of repetitions 2, the required sample size is about 100 subjects.The patients who met the inclusion criteria will be recruited. The purpose, significance, and procedures of the study will be explained to them, and written informed consent Will be obtained before enrollment.The researcher will measure the wounds and collect disease-related data during dressing changes. The participants will then be asked to fill out the questionnaires by themselves or with the help of the researcher.Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much). On obtaining at least 75% response, the researcher calculated a second-order global score as well as scores for every dimension as the mean of the respective responses. Higher scores indicated greater impairment of the quality of life.

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Conditions studied

  • Chronic Wound

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Keywords

  • Validity and reliability. .
  • Arabic version QOL questionnaire
  • chronic wound
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 100 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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)

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 1 group suffering from chronic wound

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

    Other: Arabic version QOL questionnaire

Interventions

  • OtherArabic version QOL questionnaire

    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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: outcome measure will be applied after one month of wound injury

  2. 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

    Time frame: outcome measure will be applied after one month of wound injury

  3. 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

    Time frame: outcome measure will be applied after one month of wound injury

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Study locations

1 site
  • Cairo University
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06838234
Lead sponsor
Cairo University
Responsible party
Mariam Harown Boshra Eskandar (Physiotherapist at 23rd of July hospital,M.SC physiotherapy, Cairo university, Cairo University) — Principal investigator
First posted
Feb 20, 2025
Start date
Aug 2, 2024
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024
Last update
Feb 20, 2025

Study contacts

Karim I Abo Khalil safaan
principal investigator · Assistant Professor at surgery and burn Department , Faculty of Physical Therapy Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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