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Efficacy and tolerance of calcium alginate versus vaseline gauze dressings in the treatment of diabetic foot lesions.

Abstract

BACKGROUND

The study aimed at comparing the efficacy and tolerance of an alginate wound dressing with a vaseline gauze dressing in the treatment of diabetic foot lesions.

METHODS

This open-label randomized multicenter controlled study was designed to assess the effect of an up to 6-week treatment with either calcium alginate or vaseline gauze dressings. Lesions were either acute or chronic, under cleansing, and with a surface area of 1-50 cm(2); osteomyelitis and severe hypovascularization were non-inclusion criteria. Dressings were changed every day then, once granulation had occurred, every 2 to 3 days. Primary outcome was the proportion of patients with granulation tissue over 75% of the wound area and having a 40% decrease in wound surface area; secondary outcomes were pain on dressing changes, the number of dressing changes, and adverse events.

RESULTS

Seventy-seven patients were enrolled. Due to the premature cessation of treatment in 13 patients, it was decided to reduce the period of the efficacy analysis to 4 weeks (without revising the criteria of efficacy). The success rate was of 42.8% in the calcium alginate group and of 28.5% in the vaseline gauze group (not significant difference). A subsequent analysis of granulation tissue surfaces covering the wounds at week 4 (all surfaces taken together) showed a superiority of calcium alginate (p=0.04). Pain on dressing change was lower in the calcium alginate group (p=0.047) and the total number of dressing changes tended also to be lower (p=0.07). Adverse events, which occurred 4 times in the calcium alginate group and 6 times in the other, were judged independent of the treatments.

CONCLUSIONS

As compared with vaseline gauze, calcium alginate appears to be more appropriate for topical treatment of diabetic foot lesions in terms of both healing and tolerance.

Authors+Show Affiliations

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Service d'Endocrinogie-Nutrition, Hôpital Sud, Amiens.

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Source

Diabetes & metabolism 28:3 2002 Jun pg 223-9

MeSH

Age of Onset
Alginates
Bandages
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabetic Foot
Female
Follow-Up Studies
France
Glucuronic Acid
Glycated Hemoglobin A
Hexuronic Acids
Humans
Male
Middle Aged
Petrolatum
Time Factors
Treatment Outcome
Wound Healing

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

12149603

Citation

Lalau, J D., et al. "Efficacy and Tolerance of Calcium Alginate Versus Vaseline Gauze Dressings in the Treatment of Diabetic Foot Lesions." Diabetes & Metabolism, vol. 28, no. 3, 2002, pp. 223-9.
Lalau JD, Bresson R, Charpentier P, et al. Efficacy and tolerance of calcium alginate versus vaseline gauze dressings in the treatment of diabetic foot lesions. Diabetes Metab. 2002;28(3):223-9.
Lalau, J. D., Bresson, R., Charpentier, P., Coliche, V., Erlher, S., Ha Van, G., ... Richard, J. L. (2002). Efficacy and tolerance of calcium alginate versus vaseline gauze dressings in the treatment of diabetic foot lesions. Diabetes & Metabolism, 28(3), pp. 223-9.
Lalau JD, et al. Efficacy and Tolerance of Calcium Alginate Versus Vaseline Gauze Dressings in the Treatment of Diabetic Foot Lesions. Diabetes Metab. 2002;28(3):223-9. PubMed PMID: 12149603.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerance of calcium alginate versus vaseline gauze dressings in the treatment of diabetic foot lesions. AU - Lalau,J D, AU - Bresson,R, AU - Charpentier,P, AU - Coliche,V, AU - Erlher,S, AU - Ha Van,G, AU - Magalon,G, AU - Martini,J, AU - Moreau,Y, AU - Pradines,S, AU - Rigal,F, AU - Wemeau,J L, AU - Richard,J L, PY - 2002/8/1/pubmed PY - 2003/1/1/medline PY - 2002/8/1/entrez SP - 223 EP - 9 JF - Diabetes & metabolism JO - Diabetes Metab. VL - 28 IS - 3 N2 - BACKGROUND: The study aimed at comparing the efficacy and tolerance of an alginate wound dressing with a vaseline gauze dressing in the treatment of diabetic foot lesions. METHODS: This open-label randomized multicenter controlled study was designed to assess the effect of an up to 6-week treatment with either calcium alginate or vaseline gauze dressings. Lesions were either acute or chronic, under cleansing, and with a surface area of 1-50 cm(2); osteomyelitis and severe hypovascularization were non-inclusion criteria. Dressings were changed every day then, once granulation had occurred, every 2 to 3 days. Primary outcome was the proportion of patients with granulation tissue over 75% of the wound area and having a 40% decrease in wound surface area; secondary outcomes were pain on dressing changes, the number of dressing changes, and adverse events. RESULTS: Seventy-seven patients were enrolled. Due to the premature cessation of treatment in 13 patients, it was decided to reduce the period of the efficacy analysis to 4 weeks (without revising the criteria of efficacy). The success rate was of 42.8% in the calcium alginate group and of 28.5% in the vaseline gauze group (not significant difference). A subsequent analysis of granulation tissue surfaces covering the wounds at week 4 (all surfaces taken together) showed a superiority of calcium alginate (p=0.04). Pain on dressing change was lower in the calcium alginate group (p=0.047) and the total number of dressing changes tended also to be lower (p=0.07). Adverse events, which occurred 4 times in the calcium alginate group and 6 times in the other, were judged independent of the treatments. CONCLUSIONS: As compared with vaseline gauze, calcium alginate appears to be more appropriate for topical treatment of diabetic foot lesions in terms of both healing and tolerance. SN - 1262-3636 UR - https://www.unboundmedicine.com/medline/citation/12149603/Efficacy_and_tolerance_of_calcium_alginate_versus_vaseline_gauze_dressings_in_the_treatment_of_diabetic_foot_lesions_ L2 - https://medlineplus.gov/diabeticfoot.html DB - PRIME DP - Unbound Medicine ER -