Authors' objectives:

To assess the clinical- and cost-effectiveness of prevention and treatment strategies for diabetic foot ulcers and systemic and topical antimicrobial agents in the prevention and healing of chronic wounds.

Authors' results and conclusions: Prevention of diabetic foot ulcers There is some evidence (1 large trial) that a screening and foot protection programme reduces the rate of major amputations. The evidence for special footwear (2 small trials) and educational programmes (5 trials) is equivocal. A single trial of podiatric care reported a significantly greater reduc-tion in callus in patients receiving podiatric care. Treatment of diabetic foot ulcers Total contact casting healed significantly more ulcers than did standard treatment in one study. There is evidence from 5 trials of topical growth factors to suggest that these, particularly platelet-derived growth factor, may increase the healing rate of diabetic foot ulcers. Although these studies were of relatively good quality, the sample sizes were far too small to make any definitive conclusions, and growth factors should be compared with current standard treatments in large, multicentre studies. Topical ketanserin increased ulcer healing rate in 2 studies, while systemic hyperbaric oxygen therapy reduced the rate of major amputations in 1 study. Preliminary research into the effects of iloprost and prostaglandin E1 (PGE1) on diabetic foot ulcer healing suggests possible benefits. However, good quality, large-scale confirmatory research is needed. Topical dimethyl sulphoxide (DMSO) (1 trial), glycyl-L-histidyl-L-lysine:copper (1 trial) and topical phenytoin (1 trial) were associated with increased healing. There is no good evidence in favour of any other dressing from 9 small trials, or for skin replacement dressings from 2 trials (the larger of which suffered substantial loss to follow-up). Antimicrobials Thirty studies were included, 25 with a randomised design. There were nine evaluations of systemic antimicrobials and 21 of topical agents. Venous leg ulcers DMSO powder produced significantly higher healing rates than placebo, but was equivalent to allopurinol powder. Results were conflicting for silver-based products (silver sulphadiazine and silver-impregnated activated charcoal dressing). There was no evidence in favour of systemic -antibiotics, polynoxylin paste, mupirocin 2% impregnated dressing or povidone iodine 10%. Mixed aetiology wounds Systemic ciprofloxacin added to a topical regimen produced increased healing rates in 1 trial. Levamisole (primarily used to treat roundworm infection) was associated with significantly higher healing rates than placebo (1 trial). The results for benzoyl peroxide were equivocal. 1% silver-zinc allantoinate cream was more effective than a variety of other topical preparations in a single small study. No differences were found between a hydrocolloid dressing and povidone iodine ointment for complete healing in patients with leg ulcers (aetiology unspecified) or pressure ulcers. No differences were found between an antiseptic spray (eosin 2% and chloroxylenol 0.3%) and an alternative preparation in patients with diabetic foot ulcers or pressure ulcers. Pressure ulcers There is no evidence in favour of topical anti-microbials in pressure-sore prevention. Oxy-quinoline ointment was significantly more effective than a standard emollient for treating pressure sores in 1 study. No significant difference was detected between a hydrocolloid dressing and povidone iodine ointment, or between a gentian violet preparation and povidone iodine/sugar ointment. Diabetic foot ulcers No beneficial effect of topical or systemic anti-biotics was identified. Pilonidal sinuses Oral metronidazole given after excision resulted in significantly shorter healing time (1 study). Gentamicin-impregnated sponge produced significantly higher rates of primary healing than no sponge.

Authors' recommendations: Much uncertainty remains over the most effective interventions for the prevention and treatment of diabetic foot ulcers. Certain treatments (e.g. growth factors and off-loading techniques such as total contact casting) show promise but need further, more rigorous evaluation. There is no existing evidence to support the use of systemic antimicrobial agents for chronic wound healing. Even with interventions that appear to be promising, further, more rigorous evaluation is required before use becomes routine, as existing trials are generally small and many have other methodological problems. Several topical agents may be helpful, but again further research is required to establish effectiveness. Until improved data on relative effectiveness become available, considerations such as cost-minimisation may be used to guide decisions on the use of antimicrobial agents.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.hta.ac.uk/9120085

Year Published: 2000

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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