Immunomodulatory role of Tinospora cordifolia as an adjuvant in surgical treatment of diabetic foot ulcers: a prospective randomized controlled study.
BACKGROUND
Chronic diabetic patients with wounds have deficient growth factors and impaired local and systemic cellular immunity. Treatment with growth factors is expensive with risk of infection transmission and these factors may not achieve optimum wound concentration. We evaluated the role of generalized immunomodulation in diabetic ulcers by using Tinospora cordifolia as an adjuvant therapy and studied its influence on parameters/determinants of healing, on bacterial eradication and on polymorphonuclear phagocytosis.


METHODS
A prospective double-blind randomized controlled study lasting for over 18 months in 50 patients. The ulcer was classified by wound morphology and severity with Wound Severity Score (Pecoraro-Reiber system). Mean ulcer area, depth and perimeter were measured and swabs taken for culture. Blood was collected to assess polymorphonuclear % phagocytosis (PMN function by Lehrer-Cline C. albicans method). Medical therapy, glycemic control, debridement, wound care were optimized. At 4 weeks, parameters were reassessed. PMN function was reviewed at 3 months.


RESULTS
Forty-five patients completed the trial: study group - 23 (M:F = 17:1; mean age = 56.3 years; mean ulcer duration = 21.1 days); control group 22 (M:F = 19:3; mean age = 56.3 years; mean ulcer duration = 30.4 days). Net improvement was seen in 17 patients (73.9%) in the study group; while in the control group, in 13 patients (59.1%); P = 0.292. Specific parameters included rate of change of ulcer area - cm(2) /day (study - 0.15; control - 0.07; P = 0.145); rate of change of ulcer perimeter - mm/day (study - 0.09; control = - 0.07; P = 0.089); change of depth - mm (study - 2.2; control - 1.4; P = 0.096); change of wound score (study - 14.4; control - 10.6; P = 0.149); total number of debridements (study - 1.9; control - 2.5; P = 0.03) and change in % phagocytosis (study - 3.9; control - 2.3; P = 0.048).


CONCLUSIONS
Diabetic patients with foot ulcers on T. cordifolia as an adjuvant therapy showed significantly better final outcome with improvement in wound healing. Reduced debridements and improved phagocytosis were statistically significant, indicating beneficial effects of immunomodulation for ulcer healing.
Purandare
Harshad
H
Department of Surgery, Seth G. S. Medical College and K. E. M. Hospital, Mumbai, India.
Supe
Avinash
A
D043925:Angiogenesis Inducing Agents / Q000191:economics / Q000627:therapeutic use; D000077214:Becaplermin; D017719:Diabetic Foot / Q000188:drug therapy* / Q000276:immunology / Q000601:surgery; D004311:Double-Blind Method; D005260:Female; D016523:Foot Ulcer / Q000188:drug therapy* / Q000276:immunology / Q000601:surgery; D006801:Humans; D008297:Male; D009504:Neutrophils / Q000187:drug effects; D008517:Phytotherapy / Q000379:methods*; D028321:Plant Preparations / Q000627:therapeutic use; D010982:Platelet-Derived Growth Factor / Q000191:economics / Q000627:therapeutic use; D011446:Prospective Studies; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins; D031610:Tinospora / Q000276:immunology*; D014945:Wound Healing / Q000187:drug effects* / Q000276:immunology
D043925:Angiogenesis Inducing Agents; D028321:Plant Preparations; D010982:Platelet-Derived Growth Factor; D020574:Proto-Oncogene Proteins c-sis; D011994:Recombinant Proteins; D000077214:Becaplermin