Introduction

The World Health Organization defines Diabetic Foot Syndrome (DFS) as an ulceration of the foot associated with infection, neuropathy, and ischemia [1]. Threatening limb and life, DFS, is one of the most serious complications of diabetes [2]. Rapidly spreading infection in the diabetic foot can lead to extensive tissue destruction necessitating amputation. Prompt diagnosis and intervention reduces the risk of complications including amputation, sepsis, and death [3]. In addition to antibiotic therapy, surgery to remove necrotic material, including the fascial tissue, and drain pockets of purulence is the mainstay of treatment [4]. In most cases, the initial procedure for the severely infected diabetic foot does not remove all the nonviable and infected tissue. Repeat operative debridement is required [5]. The goal of treatment, once the acute infection subsides, focuses on reconstruction of the anatomy and wound closure. For many years, local flaps and split thickness skin grafting have played an integral role in the surgical approach [6]; however, these procedures require a granulating, uninfected wound bed without the presence of biofilm [7,8]. The addition of local agents that accelerate the debridement process may reduce the time to grafting or flap closure. In this case series, surgical debridement was combined with a novel topical desiccating agent (TDA)(DEBRICHEM, DEBx Medical B.V., Amsterdam, Netherlands) applied at the time of the initial surgical intervention in patients with severe diabetic foot infections. The goal was to supplement surgical debridement by removing residual infected tissue and disrupting biofilm and thereby decreasing the time to definitive closure.

Several studies suggest that acid-based desiccants are effective in the treatment of periodontal disease [9-11]. It is believed that the desiccants remove nonviable tissue and dehydrate and destroy biofilm [12]. Skin and soft tissue infections, like periodontal infections, have high bacterial bioburden, complex biofilm formation and high levels of inflammatory proteases; however, the desiccants used to treat periodontal disease are too astringent for open wounds. The novel topical desiccant agent used in this study is, formulated by combining 83% methanesulfonic acid with proton acceptors and dimethyl sulfoxide. This combination is more suitable for open wounds [13].

Materials and Methods

This study was conducted by the primary author at a single medical center. It received ethics committee approval for publication by the local institutional review board (Ethical Board Approval, Date:14.02.2024 Number: AEŞH-BADEK-2024-124, Ankara Etlik Şehir Hastanesi). Prior to surgery, all patients signed an informed consent that included the publication of deidentified information and photography. Eleven(11) patients suffering from severe diabetic foot infections with necrotizing fasciitis of plantar and/or dorsal facia of the foot were treated through a combined surgical and chemical debridement approach using a topical desiccating agent. Six of the 11 patients were recommended below-the-knee amputation at other hospitals. Preoperative evaluation, included history and physical examination, X-rays and comprehensive laboratories. Patient demographics and an overview of laboratory findings are shown in table 1. Broad spectrum antibiotics were started prior to taking the patient to the operating room because of the accompanying sepsis. The surgical intervention involved the excision of necrotic material, infected tissue, and drainage of abscesses. All the procedures were performed under a popliteal nerve block to minimize the risks associated with general anesthesia. Following the surgical debridement and thorough irrigation of the affected area, the topical desiccating agent was applied to further aid in debridement and biofilm control. Postoperatively, antibiotic therapy was continued to mitigate the risk of secondary infections and facilitate recovery. Repeat operative debridement was performed at the discretion of the surgeon. After resolution of the acute infection, the patients underwent split thickness skin grafting for wound closure. 

Table 1: Patient Demographics.

Case Studies

Case 1: A 62-year-old male with long standing diabetes mellitus was referred to the surgery department for treatment of a Wagner 4 diabetic foot ulcer on the right heel. The ulcer had been present for several weeks (Figure 1). His medical history included diabetes mellitus primarily treated with oral hypoglycemic agents. He had a history of coronary artery disease and suffered an acute myocardial infarction 20 years earlier and treated with a percutaneous coronary intervention (PCI). He had peripheral arterial disease for which he underwent stenting of an 80% occlusion of the right iliac artery and 100% occlusion of the right superficial femoral artery, in the month prior to admission. His blood work on admission is shown in Table 2. The patient’s severe diabetic foot infection required immediate surgical intervention which included a prompt surgical drainage and debridement, complemented with chemical debridement with a topical desiccating agent spread over all the exposed surface of the wound (Figure 2). Three days post-surgery the patient underwent further surgical debridement and negative pressure wound therapy was initiated (Figure 3). Following a four-month healing period, during which the wound developed adequate granulation tissue, the patient underwent a successful grafting procedure (Figure 4). He had 100% graft take and complete wound closure (Figure 5).

Table 2: Blood work on admission.

Figure 1: Upon admission.

Figure 2: Surgical debridement, and application of topical desiccating agent (right upper photo).

Figure 3: Negative pressure wound therapy installed on the third postoperative day.

Figure 4: Grafting 4 months after the initial operation.

Figure 5: Healed Wound, 2.5 months post-operative. (2.5 months post-grafting).

Case 2: A 61-year-old male was referred to the general surgery department from the infectious disease department for treatment of a bullous lesion on the medial dorsal surface of the left foot. His medical history included diabetes mellitus, hypertension, cataract surgery in 2016, and cessation of smoking 25 years prior. Upon admission, the physical examination revealed purulent discharge from the wound suggestive of a deep infection. His lab work corroborated the physical findings: he had leukocytosis, and elevated C-reactive protein (Table 3, Figure 6). The patient underwent a metatarsophalangeal joint disarticulation (first toe amputation), metatarsal head resection due to osteomyelitis, drainage through a created skin tunnel and chemical debridement with a topical desiccating agent (Figure 7). 

Table 3: Laboratory Values.

Figure 6: First day of admission.

Figure 7: Intraoperative.

On post-operative day 4 debridement and irrigation were repeated in the operating room and, negative pressure wound therapy was applied (Figure 8). On post-operative day eleven debridement, partial suturing of the amputation defect was performed and negative pressure wound therapy continued. On post-operative day 21 the patient underwent total callus and ulcer excision in addition to delayed primary closure. All of his wounds were closed by post-operative day 35 and he was discharged from the hospital.

 Figure 8: Day four of admission.

On his first follow up visit, 3 weeks later, an abscess was noticed with elevated c-reactive protein levels, the patient was taken to the OR for an emergency drainage. Post-procedure, magnetic resonance image and bone scintigraphy were obtained. The patient was advised to maintain strict bed rest to offload the wound. Fifteen days later, grafting was performed on both defects (Figure 9). He achieved complete closure as shown in Figure 10.

Figure 9: Photo of the follow up visit and, after the graft.

Figure 10: Photos of Follow-up 2 months after grafting.

Results

All eleven patients (8 male, 3 female) had a satisfactory reconstructive result. The average age of the patients was 58 years old. They required an average of 1.7 surgical debridement procedures and 1 chemical procedure (overall average of debridement procedures is 2.45). Patients’ wound duration ranged from 1 week to 5 months. The minimum time to grafting was 33 days, with a maximum time to grafting of 4 months. The median LRINEC score on admission for the eleven patients was 9 indicating the presence of a necrotizing infection [14]. The median LRINEC score on Day 7 for the 11 patients was 3 (Tables 4,5). There were no adverse events related to TDA.

Table 4: Summary of 11 patients - LRINEC.

Table 6: Summary of Time to Grafting.