Status:
UNKNOWN
Vibration Enhances Diabetic ULCER Healing
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Objectives: Diabetes has a prevalence of 11.6% in China with diabetic foot ulcerations affecting over 30 million Chinese. 85% of these patients require amputation and 5-year mortality for diabetics i...
Detailed Description
Plan of Investigation: (fig 04 in supplementary notes, CONSORT diagram) Subjects: Participants will be recruited from the patients in the Orthopaedic \& Traumatology department at the Prince of Wale...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \>18 years old (legally able to self-sign consent)
- Able to stand independently
- Biochemically confirmed Diabetes with a fasting plasma glucose ≥ 7.0 mmol/L, or a random plasma glucose ≥ 11.1 mmol/L or hemoglobin A1c (HbA1c) level ≥ 6.5%
- Ulcers will be below the level of the malleoli, excluding those confined to the interdigital web space
- Cross-sectional area of the index ulcer should be 50- 1000 mm2
- Wagner stage 2-3
- Not active infection according to the Infectious Diseases Society of America guidelines
- Exclusion criteria:
- Severe cognitive impairment or severe comorbidity, which may impair ability to adhere to intervention plan, e.g. severe dementia, poor cardiopulmonary reserve requiring home oxygen, daily hemodialysis etc.
- Evidence of active infection
- Recent revascularization procedure (\<12 weeks)
- Recently received medication/intervention which might affect cell proliferation (eg chemotherapy, radiotherapy etc)
- Allergy to dressing, adhesives or antibiotics
- Incapable to understand the study protocol or provide written informed consent
Exclusion
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04275804
Start Date
January 1 2022
End Date
December 31 2024
Last Update
July 28 2021
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