Efficacy and safety of treatment of diabetic foot using intralesional infiltration of epidermal growth factor in Libyan patients
Abstract
Previous studies have shown the effectiveness of intralesional infiltration of Epidermal Growth Factor in enhancing development of granulation tissue in high grades of diabetic foot. In our study the aim was to examine the clinical effects of the administration of Epidermal Growth Factor up to formation of > 75% of the area of the ulcer. 107 patients with neuropathic, ischemic or mixed diabetic foot ulcers or amputation residual ulcers. Patients were admitted to surgical department received standardized wound care. Average size of ulcer is 8 cm2, average number of infiltrations 4 (2;14). Adverse side effects were pain at site of infiltration, shivering, and chills. Our results showed that 80.3% of patients achieved 75% or more of functional granulation tissue in 2 weeks periods. Amputation was necessary in 1 case. Treatment of DFU with EGF is safe, effective and fast in formation of functional granulation tissue.
References
1-Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27: 1047–53.
2-Kadiki OA, Roaed RB. Epidemiological and clinical patterns of diabetes mellitus in Benghazi, Libyan Arab Jamahiriya. East Mediterr Health J 1999;5(1):6-13.
3-Abbott CA, Carrington AL, Ashe H, Bath S, Every LC, Griffiths J, Hann AW, Hussein A, Jackson N, Johnson KE, Ryder CH, Torkington R, Van Ross ER, Whalley AM, Widdows P, Williamson S, Boulton AJ; North-West Diabetes Foot Care Study. The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabetic Med 2002;19:377–384.
4-Frykberg RG, Armstrong DG, Giurini J, Edwards A, Kravette M, Kravitz S, Ross C, Stavosky J, Stuck R, Vanore J. Diabetic foot disorders. A clinical practice guideline. J Foot Ankle Surg 2000;39(5 Suppl):S1–S60.
5- Gordois A, Scuffham P, Shearer A, Oglesby A, Tobian JA. The health care costs of diabetic peripheral neuropathy in the US. Diabetes Care 2003; 26: 1790-5.
6- Gordois A, Scuffham P, Shearer A, Oglesby A. The healthcare costs of diabetic peripheral neuropathy in the UK. The Diabetic Foot 2003; 6: 62-73.).
7- Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care 1998;21:822–7.
8- Margolis DJ, Bartus C, Hoffstad O, Malay S, Berlin JA. Effectiveness of recombinant human platelet-derived growth factor for the treatment of diabetic neuropathic foot ulcers.Wound Repair Regen 2005;13:531–6.
9- Rullan M, Cerd`a L, Frontera G, Masmiquel L, Llobera J.Complications treatment of chronic diabetic foot ulcers with bemiparin: a randomized, triple-blind, placebo-controlled, clinical trial. Diabetic Med 2008;25:1090–5.
10- Veves A, Falanga V, Armstrong DG, Sabolinski ML. Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomizedmulticenter clinical trial. Diabetes Care 2001;24:290–5.
11-Marston WA,Hanft J, Norwood P, Pollak R.Dermagraft diabetic foot ulcer study group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized. Diabetes Care 2003;26:1701–5.
12- Boonstra J, Rijken P, Humbel B, Cremers F, Verkleij A, van Bergen en Henegouwen P. The epidermal growth factor. Cell Biol Int 1995;19:413–30.).
13 -Berlanga J, Moreira E, Perez L, Boix E, Gonzalez T, Lopez-Saura P. Wound healing promotion in rats treated with EGF is dose dependent. Biotecnologia Aplicada 1996;13:181–5.
14- Berlanga J, Lodos J, Labarta V, Merino N, Gonzalez T, Hayes O, Puentes P, Lopez-Saura P. The effect of the epidermal growth factor treatment schedule on the healing of full-thickness wounds in pigs. Biotecnologia Aplicada 1997;14:163–8.).
15- Prats PA, Castan˜ eda LO, Falco´n V, Ortega R, de la Rosa MC, Mene´ndez I, Labarta V, Go´mez R. Efecto del factor de crecimiento epide´rmico sobre la regeneracio´n del nervio cia´ tico transectado en ratas. Biotecnologia Aplicada 1998;15:237–41.).
16- Berlanga J, Lodos J, Reyes O, Infante JF, Caballero E, Lo´pez-Saura P. Epidermal growth factor stimulated stimulated re-epithelialization in pigs. The possible role of acute-wound proteases. Biotecnologı´a Aplicada 1998;15:83–7.).
17-Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care 1998;21:822–7.
18-Margolis DJ, Bartus C, Hoffstad O, Malay S, Berlin JA. Effectiveness of recombinant human platelet-derived growth factor for the treatment of diabetic neuropathic foot ulcers.Wound Repair Regen 2005;13:531–6.
19- Smiell JM, Wieman TJ, Steed DL, Perry BH, Sampson AR, Schwab BH. Efficacy and safety of becaplermin (recombinant human platelet derived growth factor-BB) in patients with nonhealing, lower extremity diabetic ulcers: a combined analysis of four randomized studies. Wound Repair Regen 1999;7:335–46.ok
20- Tsang MW, Wong WK, Hung CS, Lai KM, Tang W, Cheung EY, Kam G, Leung L, Chan CW, Chu CM, Lam EK. Human Epidermal Growth Factor Enhances Healing of Diabetic Foot Ulcers. Diabetes Care 2003;26:1856–1861.
21-Hong JP, Jung HD, Kim YW. Recombinant human epidermal growth factor (EGF) to enhance healing for diabetic foot ulcers. Ann Plast Surg 2006;56:394–8.
22-Berlanga J, Lodos J, Reyes O, Infante JF, Caballero E, L´opez-Saura P. Epidermal growth factor stimulated re-epithelialization in pigs. The possible role of acute-wound proteases. Biotecnolog´ıa Aplicada 1998;15:83–7.
23- Nwomeh BC, Yager DR, Cohen IK. Physiology of chronic wounds. Clin Plast Surg 1998;25:341–56.
24- Tarnuzzer RW, Schultz GS. Biochemical analysis of acute and chronic wound environments. Wound Repair Regen 1996;4:321–5.
25- Falanga V, Eaglstein WH. The trap hypothesis of venous ulceration. Lancet 1993;341: 1006–8.
26- Robson MC, Smith PD. Topical use of growth factors to enhance healing. In: Falanga V, editor. Cutaneous wound healing. London: Martin Dunitz Limited, 2001;379–98.
27- Robson MC, Stenberg BD, Heggers JP.Wound healing alterations caused by infection. Clin Plast Surg 1990;7:485–92.
2-Kadiki OA, Roaed RB. Epidemiological and clinical patterns of diabetes mellitus in Benghazi, Libyan Arab Jamahiriya. East Mediterr Health J 1999;5(1):6-13.
3-Abbott CA, Carrington AL, Ashe H, Bath S, Every LC, Griffiths J, Hann AW, Hussein A, Jackson N, Johnson KE, Ryder CH, Torkington R, Van Ross ER, Whalley AM, Widdows P, Williamson S, Boulton AJ; North-West Diabetes Foot Care Study. The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabetic Med 2002;19:377–384.
4-Frykberg RG, Armstrong DG, Giurini J, Edwards A, Kravette M, Kravitz S, Ross C, Stavosky J, Stuck R, Vanore J. Diabetic foot disorders. A clinical practice guideline. J Foot Ankle Surg 2000;39(5 Suppl):S1–S60.
5- Gordois A, Scuffham P, Shearer A, Oglesby A, Tobian JA. The health care costs of diabetic peripheral neuropathy in the US. Diabetes Care 2003; 26: 1790-5.
6- Gordois A, Scuffham P, Shearer A, Oglesby A. The healthcare costs of diabetic peripheral neuropathy in the UK. The Diabetic Foot 2003; 6: 62-73.).
7- Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care 1998;21:822–7.
8- Margolis DJ, Bartus C, Hoffstad O, Malay S, Berlin JA. Effectiveness of recombinant human platelet-derived growth factor for the treatment of diabetic neuropathic foot ulcers.Wound Repair Regen 2005;13:531–6.
9- Rullan M, Cerd`a L, Frontera G, Masmiquel L, Llobera J.Complications treatment of chronic diabetic foot ulcers with bemiparin: a randomized, triple-blind, placebo-controlled, clinical trial. Diabetic Med 2008;25:1090–5.
10- Veves A, Falanga V, Armstrong DG, Sabolinski ML. Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomizedmulticenter clinical trial. Diabetes Care 2001;24:290–5.
11-Marston WA,Hanft J, Norwood P, Pollak R.Dermagraft diabetic foot ulcer study group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized. Diabetes Care 2003;26:1701–5.
12- Boonstra J, Rijken P, Humbel B, Cremers F, Verkleij A, van Bergen en Henegouwen P. The epidermal growth factor. Cell Biol Int 1995;19:413–30.).
13 -Berlanga J, Moreira E, Perez L, Boix E, Gonzalez T, Lopez-Saura P. Wound healing promotion in rats treated with EGF is dose dependent. Biotecnologia Aplicada 1996;13:181–5.
14- Berlanga J, Lodos J, Labarta V, Merino N, Gonzalez T, Hayes O, Puentes P, Lopez-Saura P. The effect of the epidermal growth factor treatment schedule on the healing of full-thickness wounds in pigs. Biotecnologia Aplicada 1997;14:163–8.).
15- Prats PA, Castan˜ eda LO, Falco´n V, Ortega R, de la Rosa MC, Mene´ndez I, Labarta V, Go´mez R. Efecto del factor de crecimiento epide´rmico sobre la regeneracio´n del nervio cia´ tico transectado en ratas. Biotecnologia Aplicada 1998;15:237–41.).
16- Berlanga J, Lodos J, Reyes O, Infante JF, Caballero E, Lo´pez-Saura P. Epidermal growth factor stimulated stimulated re-epithelialization in pigs. The possible role of acute-wound proteases. Biotecnologı´a Aplicada 1998;15:83–7.).
17-Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care 1998;21:822–7.
18-Margolis DJ, Bartus C, Hoffstad O, Malay S, Berlin JA. Effectiveness of recombinant human platelet-derived growth factor for the treatment of diabetic neuropathic foot ulcers.Wound Repair Regen 2005;13:531–6.
19- Smiell JM, Wieman TJ, Steed DL, Perry BH, Sampson AR, Schwab BH. Efficacy and safety of becaplermin (recombinant human platelet derived growth factor-BB) in patients with nonhealing, lower extremity diabetic ulcers: a combined analysis of four randomized studies. Wound Repair Regen 1999;7:335–46.ok
20- Tsang MW, Wong WK, Hung CS, Lai KM, Tang W, Cheung EY, Kam G, Leung L, Chan CW, Chu CM, Lam EK. Human Epidermal Growth Factor Enhances Healing of Diabetic Foot Ulcers. Diabetes Care 2003;26:1856–1861.
21-Hong JP, Jung HD, Kim YW. Recombinant human epidermal growth factor (EGF) to enhance healing for diabetic foot ulcers. Ann Plast Surg 2006;56:394–8.
22-Berlanga J, Lodos J, Reyes O, Infante JF, Caballero E, L´opez-Saura P. Epidermal growth factor stimulated re-epithelialization in pigs. The possible role of acute-wound proteases. Biotecnolog´ıa Aplicada 1998;15:83–7.
23- Nwomeh BC, Yager DR, Cohen IK. Physiology of chronic wounds. Clin Plast Surg 1998;25:341–56.
24- Tarnuzzer RW, Schultz GS. Biochemical analysis of acute and chronic wound environments. Wound Repair Regen 1996;4:321–5.
25- Falanga V, Eaglstein WH. The trap hypothesis of venous ulceration. Lancet 1993;341: 1006–8.
26- Robson MC, Smith PD. Topical use of growth factors to enhance healing. In: Falanga V, editor. Cutaneous wound healing. London: Martin Dunitz Limited, 2001;379–98.
27- Robson MC, Stenberg BD, Heggers JP.Wound healing alterations caused by infection. Clin Plast Surg 1990;7:485–92.
Additional Files
Published
2018-05-23
How to Cite
Efficacy and safety of treatment of diabetic foot using intralesional infiltration of epidermal growth factor in Libyan patients. (2018). Lebda Medical Journal, 3(1), 89–94. Retrieved from https://lebmedj.elmergib.edu.ly/index.php/LMJ/article/view/65
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Lebda Medical Journal Vol. (3) 2017
