Evaluation of the safety and healing potential of a fibroin-aloe gel film for the treatment of diabetic foot ulcers

Abstract

Objective: This study aimed to develop a wound dressing prepared from the blending of silkworm fibroin and aloe gel extract for use in the treatment of diabetic foot ulcers (DFUs). Methods: Fibroin extracted from silkworm cocoons and aloe gel extract were dissolved in deionised water. pH levels were then adjusted with lactic acid solution. A simple casting technique was used to obtain the fibroin–aloe gel film. The surface morphology, hardness, flexibility and infrared spectrum of the sterilised film were tested. Swelling ratio was measured from changes in weight. The cytocompatibility of the film to human dermal fibroblast was determined using XTT assay. Hard-to-heal DFUs (grade I Wagner score) were treated with the film for four weeks. The application site was assessed for allergic reactions and/or sensitisation. Wound size was measured using standardised digital photography. Results: A total of five hard-to-heal DFUs were treated. The obtained film sterilised with ozonation showed a non-porous structure. The elongation at break and tensile strength of the wet film were 9.00±0.95% and 6.89±1.21N, respectively. Fourier-transform infrared spectroscopy data indicated the presence of amides I, II and III, of peptide linkage, which are the chemical characteristics of the fibroin. Functional groups relating to healing activity of the aloe gel extract were also found. The swelling ratio of the film immersed in water for 24 hours was 0.8±0.01. In three DFUs (40–50mm2 in size), a wound area reduction of 0.4–0.8mm2/day was observed and were healed in 2–3 weeks. The remaining two SFUs (500mm2 in size) showed a wound area reduction of 4mm2/day and were almost closed at four weeks. No allergic reaction or infection was observed in any of the wounds. Conclusion: The obtained film showed a non-porous structure, and its strength and flexibility were adequate for storage and handling. The film tended to increase the proliferation of fibroblasts. The wound dressing showed potential for accelerating the healing rate of DFUs.

Beneficial Effects of a Blended Fibroin/Aloe Gel Extract Film on the Biomolecular Mechanism(s) via the MAPK/ERK Pathway Relating to Diabetic Wound Healing

“…The cooperation of silk fibroin and aloe gel extract biomaterials has illustrated potential properties in promoting wound healing in in vitro and in vivo models, as well as in clinical trials. 12,13 Fibroin protein, comprising the silk cocoon of Bombyx mori, illustrates the remarkable biocompatibility to several cells and tissues because of its potent properties in the stimulation of the migration and proliferation of fibroblasts. 12,14 Furthermore, at the molecular level, silk fibroin accelerates signals, including AKT/mTOR and MAPK pathways extensively involved in cell migration and proliferation regulation.…”

“…Our previous studies found that the blended fibroin/aloe gel extract film demonstrates potential healing effects, based on experimentations in vitro and in vivo in streptozotocin-induced diabetic rats, and clinical trials in diabetic foot ulcer patients. , Additionally, the γ-irradiated developed film enhanced the proliferation and migration of the healthy fibroblast cells. The presence of functional groups in the blended fibroin/aloe gel film, including amides (I, II, III), glucan units, pyranoside ring, and mannose, promotes tissue repair, but the underlying molecular mechanism is still unclear .…”

Current scenario of traditional medicines in management of diabetic foot ulcers: A review

“…With very few trials, aloe vera had shown promising results in improving healing in DFU, but there are only few human trials[ 93 - 95 ] (Table 4 ) with small sample size, inadequate data, and low-level evidence. Worasakwutiphong et al [ 96 ] conducted a small pilot study by using blended silkworm fibroin and aloe gel extract for the dressing of five hard-to-heal DFU (Wagner grade 1). Spectroscopic analysis and tensile strength analysis showed favourable results.…”

“…Clinically, three DFU had a significant reduction in wound size and healed within 3 wk. The other two had healed by 4 wk[ 96 ].…”

Magnetic Resonance Imaging Data Features to Evaluate the Efficacy of Compound Skin Graft for Diabetic Foot

“…e treatment of DF mainly includes medical treatment and surgical treatment. First, according to the situation of DF wounds, different methods of debridement and dressing change should be appropriately given to remove local bacteria or infected microorganisms to promote wound healing, and systemic antibiotic treatment should be given to patients at the same time [16,17]. After long-term conservative medical treatment, the wound will not heal for a long time and even the infection will be aggravated.…”