Efficacy and tolerance of calcium alginate versus vaseline gauze dressings in the treatment of diabetic foot lesions.
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.
Lalau
J D
JD
Service d'Endocrinogie-Nutrition, Hôpital Sud, Amiens.
Bresson
R
R
Charpentier
P
P
Coliche
V
V
Erlher
S
S
Ha Van
G
G
Magalon
G
G
Martini
J
J
Moreau
Y
Y
Pradines
S
S
Rigal
F
F
Wemeau
J L
JL
Richard
J L
JL
D017668:Age of Onset; D000464:Alginates / Q000627:therapeutic use*; D001458:Bandages; D003922:Diabetes Mellitus, Type 1 / Q000628:therapy; D003924:Diabetes Mellitus, Type 2 / Q000628:therapy; D017719:Diabetic Foot / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D005602:France; D020723:Glucuronic Acid; D006442:Glycated Hemoglobin / Q000032:analysis; D006603:Hexuronic Acids; D006801:Humans; D008297:Male; D008875:Middle Aged; D010577:Petrolatum / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing
D000464:Alginates; D020723:Glucuronic Acid; D006442:Glycated Hemoglobin; D006603:Hexuronic Acids; D010577:Petrolatum