Table 3.
Bias criteria of methodology.
| Study | Bain et al. [54] | Oropallo [55] | Uckay et al. [52] | Uckay et al. (1) [51] | Gottrup et al. [56] | Lullove [57] | Manizate et al. [58] | Varga et al. [53] |
|---|---|---|---|---|---|---|---|---|
| Clinical Trials (Randomized and Cohort) Methodology | ||||||||
| Does the study have a focused question? | Y | Y | Y | Y | Y | Y | Y | Y |
| Is the study randomized with appropriate concealment method? | X | X | Y | Y | Y | X | X | Y |
| Was there some recognition that assessment of outcome could have been influenced by exposure status when blinding was not possible? | X | Y | Y | Y | Y | X | Y | X |
| Groups being studied (same or different sites) are selected from comparable source populations in all respects other than the investigated factor? | Y | X | Y | Y | Y | X | X | Y |
| Was blinding about treatment allocation performed for subjects and investigators? | X | X | Y | Y | Y | X | X | X |
| Was the only difference found is between groups the investigated treatment, i.e., large variables | X | X | Y | X | Y | X | X | X |
| How many percentage (Not more than 20%) of participants or clusters in each arm of study dropped out before study completion? | 7.9% | 0% | 8.3% | 23% | 7.7% | 0% | 0% | 10% |
| Was there a comparison made between participants throughout the entire study and those that were lost to follow up or dropped out (by exposure status)? | Y | N/A | N/A | Y | X | N/A | N/A | N/A |
| Other sources was used as evidence to demonstrate valid and reliable method of outcome assessment. | Y | Y | Y | Y | Y | X | X | Y |
| All relevant outcomes were clearly defined, are measured in a reliable, standard, and valid way | Y | Y | Y | Y | Y | Y | Y | Y |
| How well was the study done to minimise bias? | X | X | Y | Y | Y | X | X | X |
| Clinical Trials Selection of Subjects | ||||||||
| Does the study have inclusion/exclusion criteria? | Y | Y | Y | Y | Y | Y | Y | Y |
| Number of samples | Y | Y | Y | Y | Y | Y | Y | Y |
| Age (mean or median)? | 76 | 62 | 70 | 71 | 60 | 75.9 | X | 62 |
| Sex of DU patients? | ? | ? | Y | Y | Y | ? | X | Y |
| Control or comparison with another treatment or standard of care? | X | X | Y | Y | Y | X | Y | Y |
| Was there a baseline wound condition for selection? | Y | Y | Y | Y | Y | Y | Y | Y |
| Type of diabetes | X | Y | X | Y | X | X | X | Y |
| Was ankle brachial index measured and reported before selection? | X | X | Y | Y | Y | Y | Y | X |
| Was the HbA1c measured and reported? | X | X | Y | Y | Y | X | Y | Y |
| What was the median baseline wound area? | 6.5 cm2 | 7.2 cm2 | Y | Y | 4.3 cm2 | 6.4 | 14.9 | X |
| Minimum wound duration? | 4 months | 24 months | X | X | 1 month | 1 month | X | N/A |
| Outcomes Criteria | ||||||||
| Wound closure analysis? | Y | Y | ? | ? | Y | Y | Y | ? |
| Time to complete wound closure were measured appropriately? | Y | Y | X | X | X | Y | Y | Y |
| Did the study report data on either tissue granulation or exudates? | X | X | ? | ? | Y | X | X | X |
| Were there any results pertaining microbiological, pathogen, or biofilm data? | X | X | Y | Y | X | X | Y | Y |
| Does the study include an inferential statistical analysis? | X | Y | Y | Y | Y | X | Y | Y |
| Other Integrity Criteria | ||||||||
| Was there Institutional Ethical consideration? | Y | Y | Y | Y | Y | Y | Y | Y |
| Where there mentions of funding? | ? | Y | Y | Y | Y | Y | Y | X |
| Location of Site (clinical) mentioned | X | Y | Y | Y | Y | Y | X | Y |
| Year of data collection (clinical) | X | N | Y | Y | Y | Y | X | Y |
| Did authors declare/disclosure conflict of interest? | Y | Y | Y | Y | Y | Y | Y | X |
| Ratio | 16/32 (50%) | 19/32 (59%) | 25/32 (78%) | 27/32 (84%) | 29/32 (91%) | 17/32 (53%) | 18/32 (56%) | 19/32 (59%) |
Legend: (X) inadequate; (Y) adequate; (?) unclear; and (N/A) not applicable.