Diabetic Foot Clinical Trial
— DFUOfficial title:
Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey and Conventional Dressing in Healing Diabetic Foot Ulcer
NCT number | NCT02577900 |
Other study ID # | QEH-O&T-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2013 |
Est. completion date | August 2015 |
Verified date | April 2019 |
Source | Queen Elizabeth Hospital, Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether nanocrystalline silver dressing, manuka honey dressing and conventional dressing are effective in the treatment of diabetic foot ulcer.
Status | Completed |
Enrollment | 31 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - History of type 2 diabetes mellitus and - Age 40 or above with foot ulcer and - Ulcer with size equals or larger than 1 cm in diameter and - Ulcer located at or below malleolar region of foot and - Superficial ulcer, ulcer penetrates to tendon or capsule and - Ulcer without infection, mild and moderate infection and - Subject with no foreseeable surgery within 12-week study period Exclusion Criteria: - HbA1c level = 10% or - Severe ischemia with ankle-brachial index (ABI) = 0.4 or - Ulcer deep into bone and joint or - Osteomyelitis or - Severe ulcer infection or - Known allergy to manuka honey/ nanocrystalline silver or - Known case of venous ulcer or varicose vein or - Known case of benign or malignant tumor or - Known to have any auto-immune disease or - A condition requiring medication that affects the immune response or - Participation in other experimental treatment studies or - Pregnancy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Queen Elizabeth Hospital, Hong Kong | The Hong Kong Polytechnic University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Complete Healing of Ulcer During the Observation Period | The number of participants have absence of a visible wound achieved by complete epithelialization | 12 weeks | |
Secondary | Change in Ulcer Size | 12 weeks | ||
Secondary | the Change in Concentration of Matrix Metalloproteinases-9 (MMP-9) Level Inside Wound Fluid at Week 1 and Week 4 | Week 1, Week 4 | ||
Secondary | the Change in Concentration of Tumor Necrosis Factor Alpha (TNF-a) Level Inside Wound Fluid at Week 1 and Week 4 | Week 1, Week 4 | ||
Secondary | the Change in Concentration of Interleukin-1 Alpha (IL-1a) Level Inside Wound Fluid at Week 1 and Week 4 | Week 1, Week 4 |
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