Chronic WoundNCT06838234
Arabic Version QOL Questionnaire Chronic Wound
An observational study of Chronic Wound, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Chronic Wound
- What is being tested?
- Arabic version QOL questionnaire
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Aug 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
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)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of Arabic Version of the Quality of Life Questionnaire in Patients With Chronic Wound
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.
- Conditions
- Chronic Wound
- Being tested
- Arabic version QOL questionnaire
- Keywords
- Validity and reliability. ., Arabic version QOL questionnaire, chronic wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabic version QOL questionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| 1 group suffering from chronic wound | Patients who have chronic wound will answer the items of the questionnaire Receives: Other: Arabic version QOL questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: outcome measure will be applied after one month of wound injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start2 Aug 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Harown Boshra Eskandar, Cairo University
- Investigators
- Karim I Abo Khalil safaan, Principal investigator, Assistant Professor at surgery and burn Department , Faculty of Physical Therapy Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838234
- Sponsor's protocol ID
- P.T.REC/012/024127
- Status last verified
- Feb 2025
- First submitted
- 9 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Arabic Version of the Quality of Life Questionnaire in Patients With Chronic Wound
- ClinicalTrials.gov ID
- NCT06838234
- Acronym / sponsor ID
- P.T.REC/012/024127
- Conditions
- Chronic Wound
- Keywords
- Validity and reliability. ., Arabic version QOL questionnaire, chronic wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 group suffering from chronic wound | – | Other: Arabic version QOL questionnairePatients who have chronic wound will answer the items of the questionnaire |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arabic version QOL questionnaireArabic 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 | Other | 1 group suffering from chronic wound |
Primary outcome
Body subscale
Time frame: outcome measure will be applied after one month of wound injury
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
Psyche subscale
Time frame: outcome measure will be applied after one month of wound injury
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
Day life subscale
Time frame: outcome measure will be applied after one month of wound injury
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim I Abo Khalil safaan principal investigator
Assistant Professor at surgery and burn Department , Faculty of Physical Therapy Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Wound, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body subscale (time frame: outcome measure will be applied after one month of wound injury). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.