N/A
Completed N=31
Diabetic Foot Ulcer Study on Topical Interventions
Source: ClinicalTrials.gov NCT02577900 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Number of Participants With Complete Healing of Ulcer During the Observation Period — 9; 5; 4 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Healing of Ulcer During the Observation Period |
9; 5; 4 | — |
| SECONDARY Change in Ulcer Size |
97.45; 86.25; 77.51 | — |
| SECONDARY the Change in Concentration of Matrix Metalloproteinases-9 (MMP-9) Level Inside Wound Fluid at Week 1 and Week 4 |
3412.38; 5655.76; 5365.84; 5720.59; 17672.54; 1987.39 | — |
| SECONDARY the Change in Concentration of Tumor Necrosis Factor Alpha (TNF-α) Level Inside Wound Fluid at Week 1 and Week 4 |
9.93; 24.89; 9.92; 21.77; 12.44; 11.03 | — |
| SECONDARY the Change in Concentration of Interleukin-1 Alpha (IL-1α) Level Inside Wound Fluid at Week 1 and Week 4 |
1.13; 1.93; 0.62; 0.57; 2.08; 2.21 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02577900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.