Abstract
Category:
Diabetes; Other
Introduction/Purpose:
Compare the wound healing rate, cost, and convenience between Negative Pressure Wound Therapy (NPWT) and Copper OxideDressings (COD) in the management of diabetic foot wounds (DFW).
Methods:
A Randomized controlled trial (RCT) lasting three months with 46 Diabetic Foot Wounds (DFW), recovering from infectious episodes that necessitated debridement or partial foot amputation. Patients in whom the wound was stable with resolution of the infection and in whom NPWT was indicated were enrolled in the study: 23 patients in the COD arm and 23 in the control NPWT arm. NPWT was succeeded by Aquacell extra or Granuflex dressings for up to 3 months. The primary endpoint was wound size reduction, assessed by an artificial intelligence program. The study was set as a non-inferiority study with a 20% margin. Secondary endpoints were convenience to the patient and caregiver, and pain, were assessed by visual analog score (VAS); application time (minutes), and calculated cost.
Results:
Twenty-three patients participated in the study in each arm. Seven patients dropped from the study in the NPWT arm and one in the COD group. The initial wound area was 19.9±4.36 and 14.1±2.32 cm2 in the COD and NPWT arms, respectively (p=0.25).
Wound size reduction was statistically significant non-inferior of the COD Arm compared to the NPWT (p=0.04) and superior in the last visit (T-test, p=0.032).
COD therapy was more convenient for the patients - VAS was 8.44 vs. 5.33; (p=0.002) and the medical personnel (8.29 vs. 6.0; p=0.007) and less painful (1.15 vs. 2.19; p=0.67) compared to NPWT. The COD's mean application time was shorter (8.5 vs. 13.25 minutes; p< 0.001). The cost of COD was calculated to be 84% less than NPWT treatment.
Conclusion:
This RCT study indicates statistically significant non-inferiority of COD dressing therapy than NPWT in terms of wound healing rate of DFW. Better convenience and reduced costs in the COD arm justify initial copper dressing attempts in patients with diabetic foot wounds before NPWT treatment.
