BACKGROUND:Diabetic foot ulceration is a severe complication of diabetes characterized by chronic inflammation and impaired wound healing. This study aims to evaluate the effect of a medical device gel based on Adelmidrol + Trans traumatic acid in the healing process of diabetic foot ulcers. METHODS: Thirty-seven diabetic patients with foot ulcers of mild/moderate grade were treated with the gel applied daily for 4 weeks on the affected area. The following parameters were evaluated at baseline and weekly: a) wound area, measured drawing a map of the ulcer then calculated with Photoshop6 tools, b) clinical appearance of the ulcer, assessed recording the presence/absence of dry/wet necrosis, infection, fibrin, neoepithelium, exudate, redness, granulation tissue. RESULTS: Topical treatment led to progressive healing of diabetic foot ulcers with a significant reduction of the wound area and an improvement in the clinical appearance of the ulcers. No adverse events treatment-related were observed. CONCLUSIONS: The results of this open-label study show the potential benefits of Adelmidrol + Trans traumatic acid topical administration to promote re-epithelialization of diabetic foot ulcers. Further studies need to confirm the observed results.
Heel decubitus ulcerations are relatively common occurrences that can be limb threatening. There are many options to treat these ulcerations, ranging from conservative wound care to serial debridement with flap reconstruction. However, not all patients are good candidates for major reconstructive surgery. In this case, we present a 46-year-old man who failed 3 months of conservative wound care after sustaining a heel decubitus ulcer because of immobilization from a motor vehicle accident. The ulceration was treated with sharp excision of the wound with calcaneal decorticalization and use of negative-pressure wound therapy to use the localized bone marrow within the wound bed. The patient went on to heal within 3 months of operative intervention and remains healed greater than 1 year postoperatively. This technique provided the ability to use localized bone marrow to assist in wound healing without the operative morbidity of a reconstructive procedure.
We sought to develop new recombinant human epidermal growth factor (rhEGF)–containing hydrogels and to investigate their biological activity and therapeutic effects on wound healing in diabetic rats.
Levels of rhEGF released from hydrogels were measured by enzyme-linked immunosorbent assay. The cellular proliferating activity of released rhEGF was evaluated by MTT assay. Fifty-six wounded diabetic rats were randomly divided into four groups with different topical treatment daily. The therapeutic effects were evaluated by wound area measurement, histologic analysis, immunohistochemical assessment of proliferating cell nuclear antigen and B-cell lymphoma/leukemia-2, and Western blotting of EGF receptor.
The rhEGF released from the hydrogel matrix kept its bioactivity on stimulating proliferation of the BALB/c3T3 cell line. Wound closure rates on postoperative day 14 were 75.8% in the negative control group, 82.83% in the group treated with hydrogel matrix, 85.87% in the group treated with rhEGF-containing hydrogel, and 81.18% in the group treated with rhEGF solution. Compared with hydrogel matrix, rhEGF-containing hydrogel had an additional effect on induction of EGF receptor expression (P < .05). Compared with negative controls, protein expression of B-cell lymphoma/leukemia-2 was higher in the rhEGF-containing groups (P < .05). Proliferating cell nuclear antigen was induced at its highest level on day 7 in the rhEGF-containing hydrogel–treated group (P < .05).
These data from in vitro release and diabetic animal models highlight the efficacy of hydrogels as a controlled releasing system for topical application of EGFs. The rhEGF-containing hydrogel we developed holds the merits of prolonged and sustained releasing of bioactive rhEGF and therapeutic potential in enhancing diabetic wound healing. (J Am Podiatr Med Assoc 102(2): 89–98, 2012)
The utility of wound debridement has expanded to include the management of all chronic wounds, even in the absence of infection and gross necrosis. Biofilms, metalloproteases on the wound base, and senescent cells at the wound edge irreversibly change the physiologic features of wound healing and contribute to a pathologic, chronic inflammatory environment. The objective of this review is to provide surgeons with a basic understanding of the processes of debridement in the noninfected wound. (J Am Podiatr Med Assoc 100(5): 353–359, 2010)
Achieving timely healing of foot ulcers can help avoid complications such as infection and amputation; topical oxygen therapy has shown promise in achieving this. We evaluated the clinical effectiveness of Granulox, a hemoglobin spray device designed to deliver oxygen to the surface of wounds, for the healing of foot ulcers.
We conducted a single-center, prospective, randomized controlled trial comparing standard of care (once-weekly podiatric medical clinic visits) versus standard care plus adjunct Granulox therapy twice weekly in adults with foot ulcers. After a 2-week screening phase, patients in whom the index wound had healed by less than 50% were randomized 1:1. Outcome measures were collated during the trial phase at 6 and 12 weeks.
Of 79 patients enrolled, 38 were randomized. After 12 weeks, the median percentage wound size reduction compared with the size of the ulcer at the start of the trial phase was 100% for the control arm and 48% for the Granulox arm (P = .21, Mann-Whitney U test). In the former, eight of 14 foot ulcers had healed; in the latter, four of 15 (P = .14, Fisher exact test). In the control arm, two amputations and one withdrawal occurred, whereas in the Granulox arm, one unrelated death and five withdrawals were recorded.
We could not replicate the favorable healing associated with use of Granulox as published by others. Differences in wound chronicity and frequency of Granulox application might have influenced differences in study results. Granulox might perform best when used as an adjunct for treatment of chronic wounds at least 8 weeks old.
The skin on human feet presents unique environments for the proliferation of potentially pathogenic commensals. This study examined microflora changes on healthy intact skin under a semiocclusive dressing on the medial longitudinal arch of the foot to determine changes in growth, distribution, and frequency of microflora under the dressing.
Nine human participants wore a low-adherent, absorbent, semiocclusive dressing on the medial longitudinal arch of the left foot for 2 weeks. An identical location on the right foot was swabbed and used as a control. Each foot was swabbed at baseline, week 1, and week 2. The swabs were cultured for 48 hours. Visual identification, Gram staining, DNase test agar, and a latex slide agglutination test were used to identify genera and species.
Microflora growth was categorized as scant (0–10 colony-forming units [CFU]), light (11–50 CFU), moderate (51–100 CFU), or heavy (>100 CFU). Scant and light growth decreased and moderate and heavy growth increased under the dressing compared with the control. Seven different genera of bacteria were identified. Coagulase-negative Staphylococcus spp appeared most frequently, followed by Corynebacterium spp.
Changes in microflora distribution, frequency, and growth were found under the dressing, supporting historical studies. Microflora changes were identified as an increase in bioburden and reduction in diversity. The application of similar methods, using more sophisticated identification and analysis techniques and a variety of dressings, could lead to a better understanding of bacterial and fungal growth under dressings, informing better dressing selection to assist the healing process of wounds and prevent infection.