Diabetic Foot Clinical Trial
Official title:
Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey and Conventional Dressing in Healing Diabetic Foot Ulcer
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.
Patient flow The target subjects were screened in the orthopedic department of two regional
hospitals and one general outpatient clinic (GOPD). Those eligible potential subjects were
recruited after they discharged from hospital according to the selection criteria. All the
subjects were referred and intervened in an orthopedic nurse clinic a regional hospital. The
subjects were randomized into three groups through a fixed block of 10 by online software. A
sequence of assignment was generated and put into a sealed envelope by a research assistant.
The investigator did not involve in randomization process and allocation sequence. The
subjects were enrolled and allocated to different treatment arms according to the allocation
sequence.
Data collection Outcome assessor blinding was employed in this study. A research assistant
was responsible for measuring the wound size and taking clinical photo. In every clinical
visit, the research assistant waited outside the clinic until the removal and proper
cleansing of the wound by the first author so that she unaware of the topical treatment
option. The subjects would be discontinued follow up when the wound was completely healed or
till the end of 12-week study period.
Intervention All participants attended the nurse clinic for follow-up by the first author
(nurse consultant) weekly in the first four week and then biweekly till 12 weeks of follow up
period. They were nine clinical attendances totally. At each visit, sharp debridement for the
non-viable tissue and stimulation of the vascularity on the avascular tissue were performed
if needed by the first author. Then, he applied the topical dressing according to
randomization sequence.
Statistical analysis All the analysis will be carried out according to the intention-to-treat
principle. SPSS Statistics for Mac version 22 (SPSS Inc, Chicago, Illinois) was used for data
analysis. Comparison would be made among groups by Fisher's exact test for nominal data and
Kruskal-Wallis test for ordinal and scale data. The complete ulcer healing was compared among
groups by Kaplan-Meier estimates. General estimating equation (GEE) was used to compare the
ulcer size reduction rate, the wound fluid concentration of matrix metalloproteinase -9
(MMP9), tumor necrosis factor alpha (TNF-α) and interleukin-1 alpha (IL-1α) among groups.
Statistical significance was set at p < 0.05 for all tests.
Sample size calculation
- The probability of non-healing (p1) on nanocrystalline silver (nAg) group = 0.20
- The probability (p2) of non-healing on manuka honey (MH)/conventional group = 0.50
- The alpha (α) value was 0.05 and power (1-β) was 0.8
- Ratio of sample size per group was 1:1
- Therefore, the total sample subjects for 2 groups were 77. Each group needed 39
subjects. For 3 groups, the total numbers of subjects were 117.
- From the experience, 10% of patients were loss to follow up. The actual numbers of
subjects needs were 129. i.e. 43 subjects per group.
Data quality assurance In order to ensure the data quality, a research assistant was assigned
to verify the source document and other trial records were accurate, complete, kept
up-to-date and maintained. The student investigator trained the research assistant in the
data quality assurance process. The student investigator also checked the data entry sheet
with raw data every month. The responsibilities of research assistant were listed as follows.
- Check the accuracy and completeness on the case screening form and consent form.
- Verify the laboratory data in the case record form (CRF) were consistent with the
corresponding laboratory result.
- Verify the inter-current illness was reported on the CRF.
- Verify all withdrawals and dropouts of enrolled subjects from this trial were reported
and explained on the CRF.
If there was any missing data or data inconsistency, the research assistant was clarified the
data with the internal electronic record of the hospital.
Handling of missing data The nature of this study was the multiple observations of subjects
in regular censored points. Thus, the missing clinical data was handled by the last
observation carried forward. For those laboratory data, statistical method of general
estimating equation was used for the analysis on the repeated measures among groups. The
missing data was under the missing completely at random (MCAR) assumption. Therefore, the
laboratory missing data did not need to make estimation in the present study.
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