NCT06483620 Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire
| NCT ID | NCT06483620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Diabetic Neuropathies |
| Study Type | OBSERVATIONAL |
| Enrollment | 290 participants |
| Start Date | 2025-02-13 |
| Primary Completion | 2025-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 290 participants in total. It began in 2025-02-13 with a primary completion date of 2025-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
PURPOSE: This study will translate, culturally adapt, validate, and test the reliability of the Neuro Qol Arabic version to be used with diabetic patients in Arabic countries. Background: The Neuropathy- and Foot Ulcer-Specific Quality of Life instrument is a multidimensional scale was developed to assess the QoL of diabetic patients with peripheral neuropathy. Producing Arabic versions of the Translating Scale can help researchers investigate offloading treatment among the Arabic population with DFUs. Hypotheses: The study design was a cross-cultural validation of NeuroQol, the Arabic version, for patients with DFUs. Research Question: Will there be cultural adaptation, validation, and reliability between the (Neuro Qol) Arabic version and the original language?
Eligibility Criteria
Inclusion Criteria: * Arabic is their first language The absence of any other neurological diagnosis affecting the sensory and motor system, such as stroke or multiple sclerosis * Age ranges between 18 and 70 years, * History of DM diagnosed by a physician and confirmed by either hemoglobin A1c ≥6.5% or the use of hypoglycemic agents. Exclusion Criteria: * A hospital inpatient * Had pre-existing comorbidities such as cancer, shingles or other neuropathic pain entity that predated diabetes or can mimic or cause a neuropathic pain that is not arising as a result of diabetes. * Pregnant patients as diabetes may be of gestational type * Had recently experienced physical trauma that may have contributed to neuropathic pain had trauma or dermatological diseases of the skin as this could affect skin sensitivity (e.g. wounds, psoriasis and eczema).
Contact & Investigator
Engy BadrEldin S Moustafa, PhD
PRINCIPAL INVESTIGATOR
Faculty of Physical Therapy, Cairo University, Egypt
Frequently Asked Questions
Who can join the NCT06483620 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Diabetic Neuropathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06483620 currently recruiting?
Yes, NCT06483620 is actively recruiting participants. Contact the research team at engybm.saleh@cu.edu.eg for enrollment information.
Where is the NCT06483620 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06483620 clinical trial?
NCT06483620 is sponsored by Cairo University. The principal investigator is Engy BadrEldin S Moustafa, PhD at Faculty of Physical Therapy, Cairo University, Egypt. The trial plans to enroll 290 participants.