Diabetic foot ulcers combined with ischemia and infection can be difficult to treat. Few studies have quantified the level of blood supply and infection control required to treat such complex diabetic foot ulcers. We aimed to propose an index for ischemia and infection control in diabetic chronic limb-threatening ischemia (CLTI) with forefoot osteomyelitis.
We retrospectively evaluated 30 patients with diabetic CLTI combined with forefoot osteomyelitis who were treated surgically from January 2009 to December 2016. After 44 surgeries, we compared patient background (age, sex, hemodialysis), infection status (preoperative and 1- and 2-week postoperative C-reactive protein [CRP] levels), surgical bone margin (with or without osteomyelitis), vascular supply (skin perfusion pressure), ulcer size (wound grade 0–3 using the Society for Vascular Surgery Wound, Ischemia, and foot Infection classification), and time to wound healing between patients with healing ulcers and those with nonhealing ulcers.
Preoperative CRP levels and the ratio of ulcers classified as wound grade 3 were significantly lower and skin perfusion pressure was significantly higher in the healing group than in the nonhealing group (P < .05). No other significant differences were found between groups.
This study demonstrates that debridement should be performed first to control infection if the preoperative CRP level is greater than 40 mg/L. Skin perfusion pressure of 55 mm Hg is strongly associated with successful treatment. We believe that this research could improve the likelihood of salvaging limbs in patients with diabetes with CLTI.
Diabetes often causes ulcers on the feet of diabetic patients. A 56-year-old, insulin-dependent, diabetic woman presented to the wound care center with a Wagner grade 3 ulcer of the right heel. She reported a 3-week history of ulceration with moderate drainage and odor and had a history of ulceration and osteomyelitis in the contralateral limb. Rigorous wound care, including hospitalization; surgical incision and drainage; intravenous antibiotic drug therapy; vacuum-assisted therapy; and a new room temperature, sterile, human acellular dermal matrix graft were used to heal the wound, save her limb, and restore her activities of daily living. This case presentation involves alternative treatment of a diabetic foot ulcer with this new acellular dermal matrix, DermACELL.
An Assessment of Intralesional Epidermal Growth Factor for Treating Diabetic Foot Wounds
The First Experiences in Turkey
Intralesional epidermal growth factor (EGF) has been available as a medication in Turkey since 2012. We present the results of our experience using intralesional EGF in Turkey for patients with diabetic foot wounds.
A total of 174 patients from 25 Turkish medical centers were evaluated for this retrospective study. We recorded the data on enrolled individuals on custom-designed patient follow-up forms. Patients received intralesional injections of 75 μg of EGF three times per week and were monitored daily for adverse reactions to treatment. Patients were followed up for varying periods after termination of EGF treatments.
Median treatment duration was 4 weeks, and median frequency of EGF administration was 12 doses. Complete response (granulation tissue >75% or wound closure) was observed in 116 patients (66.7%). Wounds closed with only EGF administration in 81 patients (46.6%) and in conjunction with various surgical interventions after EGF administration in 65 patients (37.3%). Overall, 146 of the wounds (83.9%) were closed at the end of therapy. Five patients (2.9%) required major amputation. Adverse effects were reported in 97 patients (55.7%).
In patients with diabetic foot ulcer who received standard care, additional intralesional EGF application after infection control provided high healing rates with low amputation rates.
Although numerous studies suggest the benefit of electrical stimulation (E-Stim) therapy to accelerate wound healing, the underlying mechanism of action is still debated. In this pilot study, we examined the potential effectiveness of lower-extremity E-Stim therapy to improve tissue perfusion in patients with diabetic foot ulcers.
Thirty-eight patients with diabetic foot ulcers underwent 60 min of active E-Stim therapy on acupuncture points above the level of the ankle joint using a bioelectric stimulation technology platform. Perfusion changes in response to E-Stim were assessed by measuring skin perfusion pressure (SPP) at baseline and during 30 and 60 min of therapy; retention was assessed 10 min after therapy. Tissue oxygen saturation (SatO2) was measured using a noninvasive near-infrared camera.
Skin perfusion pressure increased in response to E-Stim therapy (P = .02), with maximum improvement observed at 60 min (11%; P = .007) compared with baseline; SPP reduced 10 min after therapy but remained higher than baseline (9%; P = .1). Magnitude of improvement at 60 min was negatively correlated with baseline SPP values (r = –0.45; P = .01), suggesting that those with lower perfusion could benefit more from E-Stim therapy. Similar trends were observed for SatO2, with statistically significant improvement for a subsample (n = 16) with moderate-to-severe peripheral artery disease.
This study provides early results on the feasibility and effectiveness of E-Stim therapy to improve skin perfusion and SatO2. The magnitude of benefit is higher in those with poorer skin perfusion. Also, the effects of E-Stim could be washed out after stopping therapy, and regular daily application might be required for effective benefit in wound healing.
Emergency department visits for lower extremity complications of diabetes are extremely common throughout the world. Surprisingly, recent data suggest that such visits generate an 81.2% hospital admission rate with an annual bill of at least $1.2 billion in the United States alone. The likelihood of amputation and other subsequent adverse outcomes is strongly associated with three factors: 1) wound severity (degree of tissue loss), 2) ischemia, and 3) foot infection. Using these factors, this article outlines the basic principles needed to create an evidence-based, rapid foot assessment for diabetic foot ulcers presenting to the emergency department, and suggests the establishment of a “hot foot line” for an organized, expeditious response from limb salvage team members. We present a nearly immediate assessment and referral system for patients with atraumatic tissue loss below the knee that has the potential to vastly expedite lower extremity triage in the emergency room setting through greater collaboration and organization.
Background: Vaporous hyperoxia therapy (VHT), a patented US Food and Drug Administration 510 (k)–cleared technology, is an adjunct therapy used in conjunction with standard wound care (SWC). Vaporous hyperoxia therapy is said to improve the health of wounded tissue by administering a low-frequency, noncontact, nonthermal, ionic, antimicrobial hydrating mist alternating with concentrated topical oxygen therapy.
Methods: Vaporous hyperoxia therapy was used to treat 36 subjects with chronic diabetic foot ulcers (DFUs) that were previously treated unsuccessfully with SWC. The average age of DFUs in the study was 11 months and the average size was over 3 cm2. Wounds were Wagner grade 2 or 3 and most commonly on the plantar surface around the midfoot. Treatment consisted of twice-weekly applications of VHT and wound debridement. Subjects were followed to wound closure, 20 weeks, or 40 treatments, whichever came first.
Results: The combination of SWC and VHT in the group that met and maintained compliance throughout the study period achieved an 83% DFU closure rate within a 20-week period. The average time for DFU closure in this study was 9.4 weeks.
Conclusions: Historical analysis of SWC shows a 30.9% healing rate of all wounds, not differentiating chronic wounds. Accordingly, SWC/VHT increases chronic diabetic foot ulcer healing rates by 2.85 times compared with SWC alone. The purpose of this study was two-fold: first, to observe the effect of VHT on healing rates and time to healing in previously nonhealing DFUs; and second, to compare VHT with SWC, topical oxygen therapy, hyperbaric oxygen therapy, and ultrasound therapy.
Background: Prediction of amputation would aid clinicians in the management of diabetic foot infections. We aimed to assess the predictive value of baseline and post-treatment levels of acute phase reactants in the outcome of patients with diabetic foot infections.
Methods: We collected data prospectively during minimum follow-up of 6 months in patients with infected diabetic foot ulcers hospitalized in Dokuz Eylul University Hospital between January 1, 2003, and January 1, 2008. After excluding patients who did not attend the hospital for follow-up visits regularly (n = 36), we analyzed data from 165 foot ulcer episodes.
Results: Limb ischemia and osteomyelitis were much more frequent in patients who underwent amputation. Wagner grade, which assesses ulcer depth and the presence of osteomyelitis or gangrene, was higher in patients who needed amputation. Ulcer size was slightly larger in the amputation group. Baseline and post-treatment C-reactive protein levels, erythrocyte sedimentation rates, white blood cell counts, and platelet counts were significantly elevated in patients who underwent amputation. Albumin levels were significantly suppressed in the amputation group. Univariate analysis showed that a 1-SD increase in baseline and post-treatment C-reactive protein levels, erythrocyte sedimentation rates, and white blood cell counts and a 1-SD decrease in post-treatment albumin levels were significantly associated with increased risk of amputation. Post-treatment C-reactive protein level was strongly associated with amputation risk.
Conclusions: Circulating levels of acute phase reactants were associated with amputation risk in diabetic foot infections. (J Am Podiatr Med Assoc 101(1): 1–6, 2011)
Use of nerve decompression in diabetic sensorimotor polyneuropathy is a controversial treatment characterized as being of unknown scientific effectiveness owing to lack of level I scientific studies.
Herein, long-term follow-up data have been assembled on 65 diabetic patients with 75 legs having previous neuropathic foot ulcer and subsequent operative decompression of the common peroneal and tibial nerve branches in the anatomical fibro-osseous tunnels.
The cohort’s previously reported low recurrence risk of less than 5% annually at a mean of 2.49 years of follow-up has persisted for an additional 3 years, and cumulative risk is now 2.6% per patient-year. Nine of 75 operated legs (12%) have developed an ulcer in 4,218 months (351 patient-years) of follow-up. Of the 53 contralateral legs without decompression, 16 (30%) have ulcerated, of which three have undergone an amputation. Fifty-nine percent of patients are known to be alive with intact feet a mean of 60 months after decompression.
The prospective, objective, statistically significant finding of a large, long-term diminution of diabetic foot ulcer recurrence risk after operative nerve decompression compares very favorably with the historical literature and the contralateral legs of this cohort, which had no decompression. This finding invites prospective randomized controlled studies for validation testing and reconsideration of the frequency and contribution of unrecognized nerve entrapments in diabetic sensorimotor polyneuropathy and diabetic foot complications. (J Am Podiatr Med Assoc 103(5): 380–386, 2013)
Background: Treatment of diabetic foot wounds remains a major health-care issue, with diabetic foot ulcers representing the most common causal pathway to lower-extremity amputation. Although several investigations have examined topical collagen-based dressings, none have specifically looked at equine pericardium. We, therefore, evaluated the effect of the equine pericardium dressing on neuropathic foot wounds.
Methods: Twenty-three consecutive patients with 34 neuropathic foot wounds were evaluated as part of a pilot study. An equine pericardium dressing was applied in a standard manner, and the patients followed a standard postapplication treatment protocol. Changes in wound size were recorded when the equine dressing was removed and 4 and 12 weeks after application. Patients underwent dressing changes every 3 to 4 days until healed or for 12 weeks.
Results: Thirty-two wounds in 22 patients were prospectively available for evaluation. On enrollment, the median wound size was 299 mm2. When the equine material was removed (mean, 2.9 weeks), 30 of the wounds (94%) had improved, with a median size of 115 mm2 and an average reduction in size of 44.3% (P < .0001). At 4 weeks, the average decrease in wound size was 52.3% (P < .0001). At 12 weeks, 15 wounds (47%) had healed.
Conclusions: This first report of equine pericardium used to treat neuropathic foot ulcerations demonstrates that the equine pericardium dressing is a safe and beneficial treatment for neuropathic wounds. (J Am Podiatr Med Assoc 99(4): 301–305, 2009)
Biochemical properties of the amniotic membrane help modulate inflammation and enhance soft-tissue healing. In controlled trials, the efficacy of dehydrated human amnion/chorion membrane (dHACM) allografts has been established. Our purpose is to describe our experience with using dHACM to treat nonhealing wounds of various etiologies.
We conducted a retrospective review of deidentified data from 117 consecutive patients treated in an outpatient clinic with dHACM allografts with wounds of various etiologies over 2 years. The decision to use advanced wound-care treatments is based on rate of healing observed after initiation of standard wound care and patient risk factors. Eligibility for treatments such as amniotic membrane allografts includes wounds without 50% reduction after 4 weeks, or earlier in patients deemed to be at high risk for nonhealing or with a history of chronic wounds. In micronized or sheet formulation, dHACM is applied to the wound weekly after sharp/mechanical debridement as necessary, and wound-care practices appropriate for wound type and location are continued.
Thirty-four percent of allograft recipients had diabetic foot ulcers, 25% had venous leg ulcers, 20% had surgical wounds, 14% had pressure ulcers, 6% had ischemic wounds, and 2% had traumatic wounds. Complete healing occurred in 91.1% of treated patients, with a mean ± SD number of weekly applications per healed wound of 5.1 ± 4.2.
In addition to wounds of diabetic origin, dHACM can significantly expedite healing in refractory wounds of varying etiologies.