Table 12:

GRADE Evidence Profile for Irremovable Cast Walkers Versus Removable Cast Walkers

Number of Studies (Design)	Risk of Bias	Inconsistency	Indirectness	Imprecision	Publication Bias	Upgrade Considerations	Quality
Percentage of Patients with a Healed Ulcer
3 (RCTs)28,30,37	Serious limitations (−1)a	Serious limitations (−1)b	No serious limitations	No serious limitations	Undetected	None	⊕⊕ Low
Time to Healing (Kaplan-Meier Analysis)
2 (RCTs)28,37	No serious limitations	Serious limitations (−1)b	No serious limitations	Serious limitations (−1)c	Undetected	None	⊕⊕ Low
Patient Satisfaction With Treatment
1 (RCT)37	No serious limitations	Could not be evaluated	No serious limitations	Very serious limitations (−2)d	Undetected	None	⊕⊕ Low
Complications
3 (RCTs)28,30,37	Serious limitations (−1)e	No serious limitations	No serious limitations	Very serious limitations (−2)f	Undetected	None	⊕ Very Low

Abbreviations: GRADE, Grading of Recommendations Assessment, Development, and Evaluation; RCT, randomized controlled trial.

^aIn two of the studies included there was some indication of possible differences in baseline characteristics between the groups (ulcer area³⁰ and glycated hemoglobin.³⁷).

^bThe results were inconsistent across studies.

^cOne study showed a statistically significant difference in time to healing between the groups, and the other study did not.

^dThe study did not provide separate information on irremovable vs. removable cast walker groups (i.e., the authors reported on the comparison of removable cast walkers and irremovable devices [total contact casting + irremovable cast walkers]. Additionally, only one small study (n = 22 and 20 in each study group) assessed the outcome.

^eTreatment complications were not defined as an outcome a priori in the studies included in this analysis.

^fVery few events were reported in the studies, leading to very low statistical power to detect a difference between groups.