The use of epidermal growth factor in diabetic foot ulcers in South Africa

  • T G Mothabeng 1 Military Hospital https://orcid.org/0000-0001-5605-7311
  • T K Ngcobo 1 Military Hospital https://orcid.org/0000-0002-9265-6562
  • N Singh 1 Military Hospital
  • S C Deprés Hospital Militar Central Doctor Carlos J Finlay
  • M A Valdés Center for Genetic Engineering and Biotechnology
  • A D Tuero Iglesias Centre for Research and Development of Medicines
  • A B Minkova Center for Genetic Engineering and Biotechnology
  • J A Buxadó Center for Genetic Engineering and Biotechnology
  • J E Baldomero Center for Genetic Engineering and Biotechnology
  • A del Río Martín Center for Genetic Engineering and Biotechnology
  • V L M González Center for Genetic Engineering and Biotechnology
Keywords: diabetes, wound, healing, EGF, granulation, angiology

Abstract

Background: Treatment of complex diabetic foot ulcers (DFU) with intra- and peri-lesional injection of recombinant human epidermal growth factor (rhEGF) has been safe and effective in clinical trials. Here, we report results on the efficacy and safety of this treatment in South Africa.

Methods: A case series of 24 patients with DFU was conducted in a tertiary hospital in Tshwane, South Africa. Patients were treated between 1 March and 15 December 2019; with good wound care (GWC) and rhEGF through section 21 (compassionate care using an unregistered medicine). The rhEGF was administered intra- and peri-lesional, three times a week. The evolution of their ulcers was monitored and documented.

Results: Twenty-two of the 24 patients completed treatment, but all patients’ wounds/ulcers were analysed and the outcomes reported. Satisfactory granulation was noticed in the two patients who withdrew. Complete granulation response and wound closure were observed in the 22 patients who completed treatment, demonstrating a treatment efficacy of 91.7%. Most (88%) reported adverse events (AEs) were mild. Serious AEs were observed in two patients, and none were judged to be directly related to the treatment.

Conclusion: This case series demonstrates that intervention with rhEGF in complex DFU has a 91.7% efficacy in a sample of South African patients, and was well tolerated. This treatment regimen suggests a milestone in the management of a complication of diabetes. It could be the answer to the high rates of amputations that plaque patients presenting with DFU.

Author Biographies

T G Mothabeng, 1 Military Hospital

Surgical Medical Services, 1 Military Hospital, South Africa

T K Ngcobo, 1 Military Hospital

Surgical Medical Services, 1 Military Hospital, South Africa

N Singh, 1 Military Hospital

Surgical Medical Services, 1 Military Hospital, South Africa

S C Deprés, Hospital Militar Central Doctor Carlos J Finlay

Department of Angiology and Vascular Surgery, Hospital Militar Central Doctor Carlos J Finlay, Cuba

M A Valdés, Center for Genetic Engineering and Biotechnology

Center for Genetic Engineering and Biotechnology, Cuba

A D Tuero Iglesias, Centre for Research and Development of Medicines

Laboratory of Bioequivalence, Centre for Research and Development of Medicines (CIDEM), Cuba

A B Minkova, Center for Genetic Engineering and Biotechnology

Center for Genetic Engineering and Biotechnology, Cuba

J A Buxadó, Center for Genetic Engineering and Biotechnology

Center for Genetic Engineering and Biotechnology, Cuba

J E Baldomero, Center for Genetic Engineering and Biotechnology

Center for Genetic Engineering and Biotechnology, Cuba

A del Río Martín, Center for Genetic Engineering and Biotechnology

Center for Genetic Engineering and Biotechnology, Cuba

V L M González, Center for Genetic Engineering and Biotechnology

Center for Genetic Engineering and Biotechnology, Cuba

Published
2022-06-20
Section
Case Report