Evaluation of wound healing of diabetic foot ulcers in a prospective clinical trial using a synthetic hybrid-scale fiber matrix

Punch grafting is an alternative treatment to enhance wound healing which has been associated with promising clinical outcomes in various leg and foot wound types. We aimed to evaluate the clinical outcomes of punch grafting as a treatment for hard-to-heal diabetic foot ulcers (DFUs). Six patients with chronic neuropathic or neuroischemic DFUs with more than 6 months of evolution not responding to conventional treatment were included in a prospective case series between May 2017 and December 2020. All patients were previously debrided using an ultrasound-assisted wound debridement and then, grafted with 4 to 6 mm punch from the donor site that was in all cases the anterolateral aspect of the thigh. All patients were followed up weekly until wound healing. Four (66.7%) DFUs were located in the heel, 1 (16.7%) in the dorsal aspect of the foot and 1 (16.7%) in the Achilles tendon. The median evolution time was 172 (interquartile range [IQR], 25th-75th; 44-276) weeks with a median area of 5.9 (IQR; 1.87-37.12) cm2 before grafting. Complete epithelization was achieved in 3 (50%) patients at 12 weeks follow-up period with a mean time of 5.67 ± 2.88 weeks. Two of the remaining patients achieved wound healing at 32 and 24 weeks, respectively, and 1 patient showed punch graft unsuccessful in adhering. The median time of wound healing of all patients included in the study was 9.00 (IQR; 4.00-28.00) weeks. The wound area reduction (WAR) at 4 weeks was 38.66% and WAR at 12 weeks was 88.56%. No adverse effects related to the ulcer were registered through the follow-up period. Autologous punch graft is an easy procedure that promotes healing, achieving wound closure in chronic DFUs representing an alternative of treatment for hard-to-heal DFUs in which conservative treatment has been unsuccessful.

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Therapeutic Properties of Honey for the Management of Wounds; Is There a Role in the Armamentarium of Diabetic Foot Ulcer Treatment? Results From In vitro and In vivo Studies

The International Journal of Lower Extremity Wounds ◽

10.1177/15347346211026819 ◽

2021 ◽

pp. 153473462110268

Author(s):

Ioanna A. Anastasiou ◽

Ioanna Eleftheriadou ◽

Anastasios Tentolouris ◽

Georgia Samakidou ◽

Nikolaos Papanas ◽

...

Keyword(s):

Wound Healing ◽

Diabetic Foot ◽

Diabetic Animal ◽

Cochrane Library ◽

Foot Ulcers ◽

Diabetic Foot Ulcers ◽

Diabetic Wound ◽

Diabetic Wound Healing ◽

Therapeutic Properties

Diabetic foot ulcers are one of the most dreadful complications of diabetes mellitus and efforts to accelerate diabetic wound healing are of paramount importance to prevent ulcer infections and subsequent lower-limb amputations. There are several treatment approaches for the management of diabetic foot ulcers and honey seems to be a safe and cost-effective therapeutic approach on top of standard of care. The aim of this review was to summarize the therapeutic properties of honey and the data regarding its possible favorable effects on diabetic wound healing. A literature search of articles from 1986 until April 2021 was performed using MEDLINE, EMBASE, and the Cochrane Library to assess for studies examining the therapeutic wound healing properties of honey, it's in vitro effect, and the efficacy and/or mechanism of action of several types of honey used for the treatment of diabetic animal wounds. Honey has antioxidant, anti-inflammatory, and antibacterial properties and in vitro studies of keratinocytes and fibroblasts, as well as studies in diabetic animal models show that treatment with honey is associated with increased re-epithelialization and collagen production, higher wound contraction, and faster wound healing. The use of honey could be a promising approach for the management of diabetic foot ulcers.

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Security and efficacy of intradermal injection of mesenchymal stem cells derivatives on chronic diabetic foot ulcers: a randomized controlled clinical trial

Cytotherapy ◽

10.1016/s1465324921002814 ◽

2021 ◽

Vol 23 (5) ◽

pp. S22

Author(s):

S.M. Becerra-Bayona ◽

V.A. Solarte-David ◽

C.L. Sossa ◽

L.C. Mateus ◽

J. Pereira ◽

...

Keyword(s):

Clinical Trial ◽

Stem Cells ◽

Mesenchymal Stem Cells ◽

Diabetic Foot ◽

Intradermal Injection ◽

Foot Ulcers ◽

Controlled Clinical Trial ◽

Diabetic Foot Ulcers ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled

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Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial

Journal of Wound Care ◽

10.12968/jowc.2021.30.sup5.s7 ◽

2021 ◽

Vol 30 (Sup5) ◽

pp. S7-S14

Author(s):

Thomas E Serena ◽

Neal M Bullock ◽

Windy Cole ◽

John Lantis ◽

Lam Li ◽

...

Keyword(s):

Clinical Trial ◽

Adverse Events ◽

Diabetic Foot ◽

Oxygen Therapy ◽

Wound Closure ◽

Foot Ulcers ◽

Controlled Clinical Trial ◽

Diabetic Foot Ulcers ◽

Open Label ◽

Number Of Patients

Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

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Surgical Treatment of Diabetic Foot Ulcers Complicated by Osteomyelitis with Gentamicin-Loaded Calcium Sulphate-Hydroxyapatite Biocomposite

Journal of Clinical Medicine ◽

10.3390/jcm10020371 ◽

2021 ◽

Vol 10 (2) ◽

pp. 371

Author(s):

Kor H. Hutting ◽

Wouter B. aan de Stegge ◽

Jaap J. van Netten ◽

Wouter A. ten Cate ◽

Luuk Smeets ◽

...

Keyword(s):

Wound Healing ◽

Surgical Treatment ◽

Treatment Regimen ◽

Diabetic Foot ◽

Prospective Trial ◽

Calcium Sulphate ◽

Foot Ulcers ◽

Ulcer Recurrence ◽

Diabetic Foot Ulcers ◽

Cox Regression Analysis

Diabetic foot ulcers, complicated by osteomyelitis, can be treated by surgical resection, dead space filling with gentamicin-loaded calcium sulphate-hydroxyapatite (CaS-HA) biocomposite, and closure of soft tissues and skin. To assess the feasibility of this treatment regimen, we conducted a multicenter retrospective cohort study of patients after failed conventional treatments. From 13 hospitals we included 64 patients with forefoot (n = 41 (64%)), midfoot (n = 14 (22%)), or hindfoot (n = 9 (14%)) ulcers complicated by osteomyelitis. Median follow-up was 43 (interquartile range, 20–61) weeks. We observed wound healing in 54 patients (84%) and treatment success (wound healing without ulcer recurrence) in 42 patients (66%). Treatment failures (no wound healing or ulcer recurrence) led to minor amputations in four patients (6%) and major amputations in seven patients (11%). Factors associated with treatment failures in univariable Cox regression analysis were gentamicin-resistant osteomyelitis (hazard ratio (HR), 3.847; 95%-confidence interval (CI), 1.065–13.899), hindfoot ulcers (HR, 3.624; 95%-CI, 1.187–11.060) and surgical procedures with gentamicin-loaded CaS-HA biocomposite that involved minor amputations (HR, 3.965; 95%-CI, 1.608–9.777). In this study of patients with diabetic foot ulcers, complicated by osteomyelitis, surgical treatment with gentamicin-loaded CaS-HA biocomposite was feasible and successful in 66% of patients. A prospective trial of this treatment regimen, based on a uniform treatment protocol, is required.

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