Table 3

Factors and pathways that may contribute to delayed healing

21-point scoring system for reports of clinical studies of the prevention and management of disease of the foot in diabetes
Study design
 1. Are adequate definitions included for the terms “ulcer,” “healing,” and all other required aspects of the population and the outcomes?
 2. Was the choice of study population appropriate for the chosen intervention and the stated outcomes?
 3. Was the control population managed at the same time as those in the intervention group?
 4. Is the intervention sufficiently well described to enable another researcher to replicate the study?
 5. Are the components of other aspects of care described for the intervention and comparator groups?
 6. Were the participants randomized into intervention and comparator groups?
 7. Were the participants randomized by an independent person or agency?
 8. Was the number of participants studied in the trial based on an appropriate sample size calculation?
 9. Was the chosen primary outcome of direct clinical relevance?
 10. Was the person who assessed the primary outcome or outcomes blinded to group allocation?
 11. Was either the clinical researcher who cared for the wound at research visits or the participant blinded to group allocation?
Study conduct
 12. Did the study complete recruitment?
 13. Was it possible to document the primary outcome in 75% or more of those recruited?
 14. Were the results analyzed primarily by intention to treat?
 15. Were the appropriate statistical methods used throughout?
 16. Was the performance of the control group of the order that would be expected in routine clinical practice?
 17. Are the results from all participating centers comparable? Answer “Yes” if the study was done in only one center.
Study reporting
 18. Is the report free from errors of reporting, e.g., discrepancies between data reported in different parts of the same report?
 19. Are the important strengths and weaknesses of the study discussed in a balanced way?
 20. Are the conclusions supported by the findings?
 21. Is the report free from any suggestion that the analyses or the conclusions could have been substantially influenced by people with commercial or other personal interests in the findings?
  • Reproduced with permission from Jeffcoate et al. (69).