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DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman (DiaFootCare)

29. oktober 2026 oppdatert av: Raqiya Mohammed Al-Mamari, Oman Ministry of Health

This study aims to evaluate DiaFootCare, a mobile health application designed to support self-care and monitoring among adults with diabetic foot ulcers. The application provides educational and self-care support, medication and care reminders, wound monitoring using standardized foot photographs, and communication of relevant information to support pharmacist-led monitoring.

The study will evaluate the usability and effectiveness of DiaFootCare among patients with diabetic foot ulcers receiving care at the National Diabetes and Endocrine Centre in Oman. Participants using DiaFootCare will be compared with participants receiving usual care. The study will assess outcomes related to diabetic foot self-care, medication adherence, glycemic control, wound healing, and participants' use of and engagement with the application.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

108

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Oman
      • Muscat, Oman, 119
        • Rekruttering
        • National Diabetes and Endocrine Centre
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

30 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • - Adults aged 30 to 80 years.
  • Diagnosed with type 1 or type 2 diabetes mellitus.
  • Have an active diabetic foot ulcer.
  • Have access to a compatible smartphone and internet connection.
  • Able to understand Arabic and use the DiaFootCare application after receiving instructions.
  • Willing and able to provide written informed consent and complete the three-month follow-up.

Exclusion Criteria:

  • Severe cognitive, visual, physical, or communication impairment that prevents use of the application or completion of study assessments.
  • A diabetic foot condition requiring immediate hospitalization or urgent major surgical intervention.
  • Unable or unwilling to complete the three-month follow-up.
  • Concurrent participation in another intervention study that could affect the study outcomes.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: DiaFootCare Intervention

Participants assigned to this arm will receive usual diabetic foot care plus access to the DiaFootCare mobile application for three months. The application provides diabetic foot self-care education, medication and self-care reminders, guided wound-image capture, wound monitoring and progress visualization, and pharmacist-led monitoring and support.
Atferdsmessig: DiaFootCare Mobile Application

Participants will use the DiaFootCare mobile application for three months in addition to usual diabetic foot care. The application provides diabetic foot self-care education, medication and self-care reminders, guided wound-image capture, wound monitoring and progress visualization, and pharmacist-led monitoring and support.

Annen: Usual Diabetic Foot Care

Participants will receive routine diabetic foot ulcer care according to usual clinical practice. They will not receive access to the DiaFootCare mobile application during the three-month study period.
Aktiv komparator: Usual Care Control

Participants assigned to this arm will receive the usual diabetic foot care provided without access to the DiaFootCare mobile application during the three-month study period.
Annen: Usual Diabetic Foot Care

Participants will receive routine diabetic foot ulcer care according to usual clinical practice. They will not receive access to the DiaFootCare mobile application during the three-month study period.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complete Wound Closure (100% Epithelialization):
Tidsramme: Baseline and 3 months

The primary effectiveness outcome is complete wound closure-defined as 100% epithelialization of the wound surface with no measurable length, width, or depth-assessed by a podiatrist masked to group allocation at Week 12 (12 weeks from baseline).
Baseline and 3 months
Wound dimensions (length, width, area)
Tidsramme: Baseline, Week 4, Week 8, Week 12

Wound dimensions-comprising length, width, and area-constitute the Primary Effectiveness Outcome in the DiaFootCare RCT
Baseline, Week 4, Week 8, Week 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Glycemic Control Measures
Tidsramme: 3 MONTHS

HbA1c levels, extracted from existing medical records, where routinely available to avoid an additional dedicated blood draw. The laboratory method and/or assay used for measuring HbA1c will be recorded to assure consistency. Where possible, measurements taken by the same lab are used
3 MONTHS
Change in Foot Care Confidence (Foot Care Confidence Scale)
Tidsramme: 3 months

Foot care self-efficacy was assessed using the Foot Care Confidence Scale (FCCS), a 12-item instrument translated via forward-backward translation and cognitive debriefing for the Omani population. Each item is rated on a 5-point Likert-type scale. Total scores range from a minimum of 12 to a maximum of 60, with higher scores indicating greater confidence in performing foot self-care.
3 months
Change in Diabetes Management Self-Efficacy (Diabetes Management Self-Efficacy Scale)
Tidsramme: 3 months

Self-efficacy in diabetes management was assessed using the Diabetes Management Self-Efficacy Scale (DMSES), a 20-item instrument translated via forward-backward translation and cognitive debriefing for the Omani population. Each item is rated on a 1-5 numerical scale reflecting the respondent's level of efficacy expectation. Total scores range from a minimum of 20 to a maximum of 100, with higher scores indicating greater self-efficacy in diabetes management.
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Oman Ministry of Health

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

13. oktober 2026

Primær fullføring (Antatt)

13. juni 2027

Studiet fullført (Antatt)

13. juni 2027

Datoer for studieregistrering

Først innsendt

6. september 2026

Først innsendt som oppfylte QC-kriteriene

6. september 2026

Først lagt ut (Faktiske)

11. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MoH/CSR/24/29355

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared because the study includes sensitive clinical information and wound images, and external data sharing is not included in the current ethics approval and participant consent.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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