Status:
NOT_YET_RECRUITING
Effectiveness of a Digital Health Education on Self-Foot Care and Quality of Life Among Patients With Diabetes
Lead Sponsor:
Universiti Putra Malaysia
Collaborating Sponsors:
University of Lahore
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
Phase:
NA
Brief Summary
Diabetes is a significant global health concern, affecting over half a billion people and leading to severe complications like diabetic foot ulcers (DFUs). The increasing incidence of DFUs highlights ...
Detailed Description
Diabetes is a major global health issue affecting over half a billion people worldwide, leading to serious complications such as diabetic foot ulcers (DFUs). The increasing incidence of DFUs necessita...
Eligibility Criteria
Inclusion
- Presence of a diabetic foot wound corresponding to Warner 2 - 4 Continuous existence of the diabetic foot lesion for a minimum of 4 weeks \< Participant has given written informed consent
Exclusion
- Age \<18 years Pregnancy Present or expected non-compliance with the requirements of the study estimated by investigator at the time point of inclusion indication for amputation above the ankle level of the same Necrotic tissue with eschar present that cannot be debrided untreated osteitis or osteomyelitis Unexplored fistula
- Malignancy of the wound Exposed nerves, vessels, or anastomotic areas
- Ambulant negative pressure wound therapy of patients with anticoagulation therapy or higher grade impaired clotting function and a heightened risk for bleeding with relevant circulatory effects
- Allergy to any disposal component of each treatment arm Severe anemia which is not caused by an infection
- Simultaneous participation in other interventional trials / previous participation in this trial
- Use of negative pressure wound therapy within 6 weeks before randomization
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 25 2025
Estimated Enrollment :
2430 Patients enrolled
Trial Details
Trial ID
NCT06538168
Start Date
July 30 2024
End Date
June 25 2025
Last Update
August 5 2024
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