Table.
GRADE evaluation of interventions for foot ulcers and amputations in diabetes
| Important outcomes | Ulcer development, amputation rates, ulcer healing rates, infection rates, and adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of interventions to prevent foot ulcers and amputations in people with diabetes? | |||||||||
| 1 (2001) | Amputation rates | Diabetes screening and protection programme v usual care | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (2001) | Ulcer development | Diabetes screening and protection programme v usual care | 4 | 0 | 0 | 0 | 0 | High | |
| 4 (1375) | Amputation rates | Patient education v usual care | 4 | –3 | –1 | –1 | 0 | Very low | Quality points deducted for flaws with randomisation, blinding, follow-up, and statistical analysis. Consistency point deducted for conflicting results. Directness point deducted for composite outcomes |
| 4 (1375) | Ulcer development | Patient education v usual care | 4 | –3 | –1 | –1 | 0 | Very low | Quality points deducted for flaws with randomisation, blinding, follow-up, and statistical analysis. Consistency point deducted for conflicting results. Directness point deducted for composite outcomes |
| 2 (469) | Ulcer development | Therapeutic footwear v usual footwear | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for randomisation flaws. Consistency point deducted for conflicting results |
| What are the effects of treatments in people with diabetes with foot ulceration? | |||||||||
| 1 (208) | Ulcer healing rates | Human skin equivalent v saline-moistened gauze | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (208) | Amputation rates | Human skin equivalent v saline-moistened gauze | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (208) | Infection rates | Human skin equivalent v saline-moistened gauze | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (40) | Ulcer healing rates | Pressure off-loading (total-contact casting) v traditional dressing changes | 4 | –1 | 0 | 0 | +1 | High | Quality point deducted for sparse data. Effect-size point added for RR greater than 2 |
| 1 (40) | Infection rates | Pressure off-loading (total-contact casting) v traditional dressing changes | 4 | –1 | 0 | 0 | +1 | High | Quality point deducted for sparse data. Effect-size point added for RR greater than 2 |
| 3 (163) | Ulcer healing rates | Pressure off-loading v removable casts/shoes | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 2 (81) | Ulcer healing rates | Pressure off-loading (total-contact cast) v removable-cast walker made non-removable | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 2 (100) | Amputation rates | Systemic hyperbaric oxygen plus usual care v usual care alone | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of results. Consistency point deducted for conflicting results |
| 6 (867) | Ulcer healing rates | Platelet-derived growth factors v placebo | 4 | 0 | 0 | 0 | 0 | High | |
| 2 (112) | Ulcer healing rates | Epidermal growth factors v placebo/control | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for sparse data. Consistency point deducted for conflicting results |
| 3 (135) | Ulcer healing rates | Protein-based topical growth factors v placebo/control | 4 | –1 | –1 | 0 | 0 | Low | Quality point deducted for sparse data. Consistency point deducted for lack of consistency in benefits with different types of topical growth factors |
| 1 (24) | Ulcer healing rates | Retinoids v saline | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 3 (198) | Ulcer healing rates | Debridement (hydrogel) v usual care | 4 | –2 | 0 | 0 | 0 | Low | Quality point deducted for sparse data and methodological flaws |
| 1 (42) | Ulcer healing rates | Surgical debridement v usual care | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for uncertainty about comparator (type of dressing) |
| 1 (140) | Ulcer healing rates | Debridement with larvae v debridement with hydrogel | 4 | –3 | 0 | 0 | 0 | Very low | Quality points deducted for sparse data, uncertain follow-up, and incomplete reporting of results |
| 6 (229) | Ulcer healing rates | Wound dressings compared with each other | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for incomplete reporting of results and for methodological flaws. Directness point deducted for large number of interventions compared |
| 1 (40) | Ulcer healing rates | Dimethyl sulfoxide v conventional treatment | 4 | –2 | 0 | –1 | +2 | Moderate | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for uncertainity about comparator. Effect-size points added for OR greater than 5 |
| 1 (35) | Ulcer healing rates | Cadexomer iodine ointment v standard dressings | 4 | –2 | 0 | –1 | +1 | Low | Quality points deducted for sparse data and incomplete reporting of results. Directness point deducted for uncertainity about comparator. Effect-size point added for OR greater than 2 |
| 1 (61) | Ulcer healing rates | Pressure off-loading with felted foam dressings v pressure-relief half-shoe | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (32) | Ulcer healing rates | Felted foam padding applied to the skin v inserted into footwear | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (28) | Ulcer healing rates | Hyperbaric oxygen plus usual care v usual care alone (non-infected ulcer) | 4 | –2 | 0 | 0 | 0 | Low | Quality point deducted for sparse data and incomplete reporting of results |
| 2 (331) | Ulcer healing rates | Human cultured dermis substitute plus usual care v usual care alone | 4 | 0 | 0 | 0 | 0 | High | |
| 2 (331) | Infection rates | Human cultured dermis substitute plus usual care v usual care alone | 4 | 0 | 0 | 0 | 0 | High |
Type of evidence: 4 = RCT; 2 = Observational Consistency: similarity of results across studiesDirectness: generalisability of population or outcomes Effect size: based on relative risk or odds ratio