Abstract
Aims
The management of diabetic foot ulcers is a challenging issue due to the pathophysiological
background, delay in healing, and prevalence of diabetes. The purpose of this study
was to compare the therapeutic effects of the three methods of diabetic wound care:
surgical debridement and dressing, dressing with dehydrated amnion powder, and dressing
with platelet-derived growth factor gel.
Methods
In this multi-arm parallel-group randomized trial, 243 patients with a minimum 4-week
medical history of diabetic foot ulcers with Wagner’s grades 1 and 2, no infection,
and adequate tissue blood flow were randomly assigned to one of three 81-person groups:
surgical debridement (the standard method), dehydrated amnion dressing, or platelet-derived
growth factor dressing. The follow-up period lasted 12 weeks. The percentage area
reduction (PAR) was measured as the final target. SPSS version 25 was used to perform
statistical analysis on the data.
Results
All three study groups were comparable in terms of the type of ulcer, the area of
ulcer, Wagner’s grade, the period, and the ulcer’s size. The PAR in the surgical debridement,
platelet-derived growth factor, and dehydrated amnion groups were 7.4%, 14.8%, and
49.3% in week 4; 20.1%, 35.8%, and 79% in week 6; 43.7%, 56.8%, 86.4% in week 8; and
50%, 61.7%, and 87.6% in weeks 10 and 12, respectively. The observed differences were
statistically significant (p < 0.05) over the entire period.
Conclusion
The study concluded that dehydrated amnion dressing, when compared to platelet-derived
growth factor dressing and surgical debridement, resulted in better-improved healing
in diabetic foot ulcer patients.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Diabetes Research and Clinical PracticeAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Global prevalence of diabetes: estimates for the year 2000 and projections for 2030.Diabetes Care. 2004 May; 27: 1047-1053
- Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always.Ther Adv Endocrinol Metab. 2018; 9: 29-31
- Consensus recommendations on advancing the standard of care for treating neuropathic foot ulcers in patients with diabetes.Ostomy Wound Manage. 2010; 56: S1-S24
- Treatment of diabetic foot ulcers with dehydrated amniotic membrane allograft: a prospective case series.J Wound Care. 2016; 25: S4-S9
- Using amniotic membrane allografts in the treatment of neuropathic foot ulcers.J Am Podiatr Med Assoc. 2014; 104: 198-202
- Healing of diabetic neuropathic foot ulcers receiving standard treatment.A meta-analysis. Diabetes Care. 1999; 22: 692-695
- Impact of various wound dressings on wound bed neoangiogenesis in patients with different forms of diabetic foot syndrome.Ter Arkh. 2017; 89: 12-16
- Treatment of Diabetic Foot Ulcers Using a Blood Bank Platelet Concentrate:.Plast Reconstr Surg. 2010; 125: 944-952
- Effectiveness of platelet releasate for the treatment of diabetic neuropathic foot ulcers.Diabetes Care. 2001; 24: 483-488
- Becaplermin: recombinant platelet derived growth factor, a new treatment for healing diabetic foot ulcers.Expert Opin Biol Ther. 2002; 2: 211-218
- Photobiomodulation therapy improves the growth factor and cytokine secretory profile in human type 2 diabetic fibroblasts.J Photochem Photobiol, B. 2020; 210: 111962https://doi.org/10.1016/j.jphotobiol.2020.111962
- Surrogate end points for the treatment of diabetic neuropathic foot ulcers.Diabetes Care. 2003; 26: 1696-1700
- Biological effects of amniotic membrane on diabetic foot wounds: a systematic review.J Wound Care. 2018; 27: S19-S25
- A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers.Int Wound J. 2015; 12: 724-732
- Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial.Plast Reconstr Surg Glob Open. 2016; 4: e1095https://doi.org/10.1097/GOX.0000000000001095
- Amnion Membrane in Diabetic Foot Wounds: A Meta-analysis.Plast Reconstr Surg Glob Open. 2017; 5: e1302https://doi.org/10.1097/GOX.0000000000001302
- The efficacy and safety of Grafix((R)) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial.Int Wound J. 2014; (1.554-60:(5)1)
- Niloofar Sodeifi, Pardis Khosravani, Niloofar Shayanasl, Marzieh Ebrahimi. In vitro and in vivo investigation of a novel amniotic-based chitosan dressing for wound healing.Wound Repair Regen. 2018; 26: 87-101
- Platelet Derived Growth Factor in healing of large diabetic foot ulcers in indian clinical set-up: a protocol-based approach.Wound Healing. 2013; 4
Rangaswamy P, Rubby SA, Prasanth K. Prospective study of platelet derived growth factor in wound healing of diabetic foot ulcers in Indian population. 2016. 2016;4(1):6.
- The preliminary application of autologous platelet-rich gel used to treat refractory diabetic dermal ulcer.Sichuan Da Xue Xue Bao Yi Xue Ban. 2007; 38: 900-903
- Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity ulcers.Plast Reconstr Surg. 2006; 117 (discussion 50S–51S): 143S-149S
- Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity diabetic ulcers. Diabetic Ulcer Study Group.J Vasc Surg. 1995; 21 (discussion 9-81): 71-78
- Recombinant human platelet-derived growth factor-BB (becaplermin) for healing chronic lower extremity diabetic ulcers: an open-label clinical evaluation of efficacy.Wound Repair Regen. 2000; 8: 162-168
Article info
Publication history
Published online: February 08, 2022
Accepted:
February 4,
2022
Received in revised form:
January 6,
2022
Received:
September 14,
2021
Identification
Copyright
© 2022 Elsevier B.V. All rights reserved.