Sodium carboxyl-methyl-cellulose dressings in the management of deep ulcerations of diabetic foot

Aims To test the safety and effectiveness of carboxyl-methyl-cellulose dres sing (Aquacel(TM); ConvaTec, Uf() in the management of deep diabetic foot u lcers, a group of consecutive out-patients attending the foot clinic of the Department of Metabolic Diseases was studied. Methods Patients were selected according to the following inclusion criteri a: a foot ulcer deeper than 1 cm for > 3 weeks, good peripheral blood suppl y (palpable peripheral pulses or ABPI > 0.9). Exclusion criteria were as fo llows: active infection, as evident from clinical signs (purulent discharge , redness, swelling, tenderness) and confirmed by culture exams, plasma cre atinine > 2 mg/dl, recent episodes of ketoacidosis, malignancies, and any t herapy or pathology which might interfere with the healing process. Twenty patients were enrolled in the study and having obtained their informed cons ent, their lesions were surgically debrided with the complete elimination o f all necrotic tissue and debris up to the bleeding healthy tissue; then ul cers were staged and measured, and patients were randomly assigned to two d ifferent treatment groups. Patients in group A were dressed with saline-moi stened gauze, while patients in group B were dressed with Aquacel(TM) accor ding to the manufacturer's instructions. All patients in both groups receiv ed special postoperative shoes (Podiabetes; Zeno Buratto, Treviso, Italy) a nd crutches until complete re-epithelialization. Ulcers were all left to he al by secondary intent. After 8 weeks patients were blindly evaluated for: the rate of reduction of lesional volume (RLV), rate of granulation tissue (GT), number of infective complications JIG). Intralesional (ILTC) and peri lesional (PLTC) temperatures were also recorded with a thermocouple surface digital thermometer, and the difference between the two values (DTC) was c alculated. Healing time (HT, days), was then compared between the two group s. Data were compared by analysis of variance (ANOVA), linear regression, K aplan-Meier survival analysis and Fisher's exact test. Results HT was significantly shorter in Group B than in Group A (P < 0.001) . RLV was significantly (P < 0.01) higher in Group B patients compared with Group A, as well as GT (P < 0.05). IC were in 1/10 Group B and in 3/10 Gro up A (P = 0.582). In addition, both ILTC and <Delta>TC were higher in Group B compared with Group A ones (P < 0.01). Conclusions Carboxyl-methyl-cellulose dressings were shown to be safe, effe ctive and well tolerated in the management of non-ischaemic, non-infected d eep diabetic foot ulcers.