ObjectiveTo explore the clinical efficacy of ultrasound debridement combined with autolytic debridement in the treatment of diabetic foot ulcers.MethodsA total of 60 diabetic foot ulcers patients who were diagnosed and treated in Jinshan Hospital of Fudan University from April 2019 to April 2020 were enrolled in the study and randomly divided into two groups, with 30 cases in each group. The trial group received autolytic cleansing combined with ultrasound debridement treatment, and the control group only received autolytic debridement treatment. The baseline conditions, wound treatment efficacy, number of dressing changes, length of hospital stay, treatment cost, wound healing time, wound shrinkage rate, and the time required for the wound to turn into 100% red granulation were compared between the two groups.ResultsThere was no statistically significant difference in gender, age, duration of diabetes or Wagner grade of diabetic foot between the two groups (P>0.05). The efficacy of wound healing in the trial group was better than that in the control group (Z=−2.146, P=0.032). The number of dressing changes [(11.76±2.23) vs. (17.34±4.43) times] and the length of stay [(18.03±3.73) vs. (25.43±4.43) d] in the trial group were lower than those in the control group, and the differences were statistically significant (P<0.05). The difference in treatment cost between the two groups was not statistically significant (P>0.05). The wound healing time of the trial group [(48.43±18.34) vs. (65.24±19.62) d], the wound shrinkage rate [(78.35±8.34)% vs. (56.53±6.54)%] and the time required for the wound to turn into 100% red granulation [(16.34±2.42) vs. (24.55±3.23) d] were better than those of the control group, and the differences were statistically significant (P<0.05). During the treatment process, no patient in the trial group had wound bleeding and had difficulty in stopping bleeding during ultrasonic debridement, and no patient had intolerable pain related to ultrasonic debridement. No patients in either group withdrew early.ConclusionsUltrasound debridement combined with autolytic debridement can effectively improve the curative effect of patients with diabetic foot ulcers and shorten the wound healing time. Therefore, it is worthy of promotion and application in the wound care of patients with diabetic foot ulcers.
ObjectiveTo observe the effect of silver dressings on treating diabetic foot ulcer infection. MethodsA total of 105 patients with diabetic foot ulcers treated from May 2012 to April 2014 were randomly divided into two groups:group A and B. Patients in group A were treated with imported silver ion alginate dressing, while group B was treated with domestic nanometer silver dressing. All patients were given basic treatment, and the effect of silver dressing was evaluated by observing bacterial clearance rate and wound healing score. ResultsThere were significant improvement in bacterial clearance rate and wound healing score in both two groups after treatment. The bacterial clearance rate was similar between the two groups (P>0.05). However, the descending trend of wound healing score in group A was significantly more obvious than group B (P<0.01). ConclusionBoth two silver dressings are effective in the treatment of diabetic foot ulcer infection, but the effectiveness of silver ion alginate dressing is superior. Bacterial clearance rate and wound healing score are objective and applicable index to evaluate the treatment effects of silver dressing.
ObjectiveTo systematically review the clinical efficacy and safety of hyperbaric oxygen therapy as adjunctive treatment for diabetic foot ulcers. MethodsSuch databases as The Cochrane Library (Issue 1, 2014), PubMed, EMbase, CBM, VIP, CNKI and WanFang Data were searched up to January 2014 for randomized controlled trials (RCTs) about hyperbaric oxygen therapy as adjunctive treatment for diabetic foot ulcers. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data, and assessed methodological quality of included studies. Then, meta-analysis was performed using RevMan 5.2 software. ResultsFourteen RCTs involving 910 patients were included. The results of meta-analysis showed that, hyperbaric oxygen therapy combined with routine therapy was superior to routine therapy alone regarding ulcer healing rates (RR=2.16, 95%CI 1.43 to 3.26, P=0.000 3), incidence of major amputation (RR=0.20, 95%CI 0.10 to 0.38, P < 0.000 01), reduction of ulcer area (MD=1.73, 95%CI 1.34 to 2.11, P < 0.000 01), and improvement of transcutaneous oxygen tension (MD=14.75, 95%CI 2.01 to 27.48, P=0.02). However, no significant difference was found between the two group in minor amputation rates (RR=0.70, 95%CI 0.24 to 2.11, P=0.53). In addition, neither relevant serious adverse reaction nor complications were reported when using hyperbaric oxygen therapy as adjunctive treatment. ConclusionCurrent evidence shows that hyperbaric oxygen therapy as adjunctive treatment could improve ulcer healing and reduce incidence of major amputation.
Objective To systematically analyze the randomized controlled trials that compare tissue-engineered skin (TES) with conventional treatment for chronic diabetic foot ulcer (DFU) in terms of effectiveness and utilization.Methods We searched the electronic databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, CBMWeb, CNKI, and VIP) in order to compare the efficiency and safety between TES and conventional treatment (CT) in the patients with DFU. In addition, we manually searched reference lists from original studies and review articles.Results Seven trials were included, which were all randomized controlled trials and had a duration of DFU over 6 weeks. There were 880 participants that met inclusion criteria in all studies, and all patients underwent pre-treatment procedures and were treated by TES (human skin equivalents, living skin equivalents or bioengineered skin, such as Graftskin, Dermagraft and Graftjacket) for 12 weeks. All trials had two groups: the treatment group and the control group, but the two trials divided the treatment groups into 3 different dosages and 2 different ulcer allocation subgroups, respectively. Meta-analysis results showed significant differences in the rate of complete wound closure (Plt;0.0001, 95%CI 0.08 to 0.20) and in the occurrence of complications and severe adverse events (P=0.008, 95%CI – 0.06 to – 0.01) between TES treated patients and conventionally treated patients. Conclusion The review shows TES improves completed closure of DFU compared with CT, and it is more effective in reducing side effects.
Objective To explore the effectiveness of microdissected thin thoracodorsal arterial perforator flap (TDAP) in repairing diabetic foot ulcers (DFUs). Methods The clinical data of 11 patients with DFUs admitted between March 2020 and February 2021 were retrospectively analyzed, including 5 males and 6 females, aged from 22 to 67 years, with an average of 49.3 years. There were 10 cases of type 2 diabetes and 1 case of type 1 diabetes; the duration of diabetes ranged from 3 months to 25 years (median, 8 months). The duration of DFUs ranged from 6 days to 120 months (median, 1 month). There were 6 cases of grade 3 and 5 cases of grade 4 according to Wagner classification. The tissue necrosis and purulent secretions were found in all ulcer wounds, as well as different degrees of tendon and bone exposure; skin defects ranged from 5 cm×3 cm to 17 cm×6 cm. The DFUs were repaired by microdissected thin TDAP, including 6 cases of flaps (including 1 case of lobulated flap), ranging from 10.0 cm×4.5 cm to 26.0 cm×7.0 cm; 5 cases of chimeric perforator flaps, the range of the flap was 10.0 cm×4.5 cm to 16.0 cm×5.5 cm, and the range of the muscle flap was 6 cm×2 cm to 10 cm×3 cm. The donor site was sutured directly. Results The operation time ranged from 3.42 to 11.17 hours, with an average of 5.92 hours. All 11 flaps survived and no vascular crisis occurred; 1 patient had a sinus at the edge of the flap, and the surgical area healed well after dressing change. All 11 patients were followed up 6-12 months, with an average of 9 months. The flap texture was good, the recipient site was in good shape, and there was no swelling; the foot contour was good, the shoes were comfortable to wear, and the movement was good. The incision at the donor site healed by first intention, leaving only linear and concealed scar, without obvious depression deformity, and the shoulder joint function was good. Conclusion On the premise of ensuring sufficient blood supply to the lower extremities and strengthening perioperative management, the microdissected thin TDAP to repair DFUs wounds can achieve better effectiveness and appearance; however, the prolonged operation time increases the probability of anesthesia and surgical risks in patients with DFUs.
Objective To provide a clinical basis for the prevention of diabetic foot ulcers by analyzing the clinical data and prognosis of high-risk diabetic foot patients. Methods A retrospective analysis was performed on high-risk diabetic foot patients who were hospitalized in West China Hospital of Sichuan University between January 1, 2012 and December 31, 2018. Patients were divided into high-risk group and low-risk group according to whether they hada history of foot ulcer or amputation. The clinical characteristics of the two groups of patients were compared. The patients were followed up from hospital discharge to January 31, 2021, and their survival and ulcer recurrence or new-onset status were evaluated. Results Finally, 123 patients were included, including 29 patients in the high-risk group and 94 patients in the low-risk group. There was no statistical difference in the duration of diabetes, smoking history, drinking history, education level, proportion of receiving regular treatment, proportion of regular blood glucose monitoring, body mass index, proportion of diabetic peripheral neuropathy, callus, foot deformity, diabetic nephropathy, diabetic retinopathy, diabetic cardiac autonomic neuropathy, diabetic gastrointestinal autonomic neuropathy, hypertension, coronary heart disease and laboratory test results between the two groups (P>0.05). The proportion of women (51.7% vs. 29.8%), age [(69.8±10.3) vs. (64.4±11.3) years], proportion of lower extremity arterial disease (62.1% vs. 34.4%), proportion of hyperuricemia (27.6% vs. 10.6%) in the high-risk group were higher than the low-risk group (P<0.05). After follow-up (67±20) months, 25.8% of the patients had ulcer recurrence or new onset, and 24.2% of the patients died. The most common cause of death was diabetes complications (43.8%). The overall 1-, 3-, and 5-year cumulative mortality rates of the patients were 4.5%, 12.7%, and 20.6%, respectively. The 3- and 5-year recurrence or new ulcer rates were 8.3% and 18.2%, respectively. The 5-year recurrence or new ulcer rates in the low-risk group and high-risk group were 10.3% and 40.3%, respectively, and there was a difference in ulcer recurrence between the two groups (P=0.004). Conclusions Compared with high-risk diabetic foot patients without ulcer or amputation, patients with a history of ulcer or amputation have higher rates of lower extremity arterial disease and hyperuricemia. Patients with a history of ulceration or amputation have a higher risk of recurrent or new ulceration than patients without a history of ulceration or amputation.
Objective To explore the feasibility and effectiveness of free vastus lateralis flap combined with skin grafting for repairing small- and medium-sized lacunar defects in the non-weight-bearing area of diabetic foot. Methods Between January 2022 and October 2023, 8 patients (8 feet) with small- and medium-sized lacunar defects in the non-weight-bearing area of diabetic foot were admitted. There were 6 males and 2 females, with an average age of 64.3 years (range, 58-76 years). The duration of the diabetic foot ulcer ranged from 2 to 7 weeks (mean, 4.3 weeks). The wound was located between the metatarsal bones in 4 cases, on the medial side of the foot in 2 cases, on the lateral side of the foot in 1 case, and on the dorsal and lateral sides of the foot in 1 case. The length of wound was 4.0-12.0 cm, the width was 3.0-5.0 cm, and the depth was 1.2-2.0 cm. The free vastus lateralis flaps were designed to repair the wounds, and skin grafting covered the vastus lateralis flaps. The length of the vastus lateralis flap was 5.0-14.0 cm, the width was 3.5-6.0 cm, and the thickness was 1.0-1.5 cm. The donor sites of the muscle flaps were directly sutured. Results The time for vastus lateralis flaps harvested ranged from 30 to 80 minutes (mean, 55.0 minutes), and the total operation time ranged from 125 to 170 minutes (mean, 147.5 minutes). All muscle flaps and skin grafts survived successfully, and the wounds and the incisions at the donor sites healed by first intention. All patients were followed up 6-24 months, with an average of 12.8 months. The appearances of 3 patients who did not follow the doctor’s instructions for pressure treatment of the muscle flaps were a little bloated, and the rest had a good appearance. The texture of the muscle flaps was soft. There were linear scars at the donor sites. There was no recurrence of ulcers during follow-up. All patients could walk independently without limitation of daily activities at last follow-up. Conclusion The application of free vastus lateralis flap combined with skin grafting to repair small- and medium-sized lacunar defects in the non-weight-bearing area of diabetic foot has the advantages of simple operation and time-saving as well as small damage to the donor site, with good repair effect, especially for the elderly patients who are not suitable for prolonged anesthesia.
Objective To evaluate the efficacy and safety of Bismuth Subgallate/Borneol (SuileTM) (BSB) dressing in the treatment of diabetic foot ulcers. Method s A two-center, randomized controlled parallel-group comparison study was conducted. Between September 2005 and November 2006, 35 patients with nonhealing diabetic foot ulcer (Wagner 2-3 grade) were recruited and divided randomly into the test group (BSB group, n=25) and control group (IG group, n=10). There was no significant difference in general data between 2 groups (P gt; 0.05). Based on the comprehensive therapy of diabetic foot, ulcers were topically treated by SuileTM dressing and Intrasite gel in the BSB group and IG group, respectively. The ulcer area was measured once a week. Ulcer bleeding was observed and acceptance of the dressing was inquired each week. Results Of the patients, 22 patients in the BSB group and 8 in the IG group completed the clinical trial. Intention to treat (ITT) analysis indicated that the results were excellent in 19 (76%) cases, good in 3 cases (12%), fair in 1 case (4%), and poor in 2 cases (8%) in the BSB group. In the IG group, the results were excellent in 8 cases (80%) cases, fair in 1 case (10%), and poor in 1 case (10%). Per-protocol (PP) analysis showed that the results were excellent in 19 cases (86%) and good in 3 cases (14%) in the BSB group, and were excellent in 8 cases (100%) in the IG group. The results of ITT and PP analysis all showed no significant difference between 2 groups (P gt; 0.05). The change trend of ulcer areas in the BSB group was similar to that in the IG group. There was no significant difference in the hemostatic effect between 2 groups (P gt; 0.05) and the patients were more likely to accept BSB dressings. Conclusion BSB dressings is an effective, safe, and generally well-tolerated therapy dressing in the treatment of diabetic foot ulcers.
Objective To investigate the effectiveness of tibial transverse transport (TTT) in treating Wagner grade 3-4 type 2 diabetic foot ulcers and analyze dynamic changes in immunoglobulin levels. Methods The clinical data of 68 patients with Wagner grade 3-4 type 2 diabetic foot ulcers treated with TTT between May 2022 and September 2023 was retrospectively analyzed. The cohort included 49 males and 19 females, aged 44-91 years (mean, 67.3 years), with 40 Wagner grade 3 and 28 grade 4 ulcers. The duration of type 2 diabetes ranged from 5 to 23 years, with an average of 10 years. The number of wound healing cases, healing time, amputation cases, death cases, and complications were observed and recorded. Serum samples were collected at 6 key time points [1 day before TTT and 3 days, 7 days (the first day of upward transverse transfer), 14 days (the first day of downward transverse transfer), 21 days (the first day after the end of transfer), 36 days (the first day after the removal of the transfer device)], and the serum immunoglobulin levels were detected by flow cytometry including immunoglobulin G (IgG), IgA, IgM, IgE, complement C3 (C3), C4, immunoglobulin light chain κ (KAP), immunoglobulin light chain λ (LAM). Results All the 68 patients were followed up 6 months. Postoperative pin tract infection occurred in 3 cases and incision infection in 2 cases. Amputation occurred in 5 patients (7.4%) at 59-103 days after operation, and 8 patients (11.8%) died at 49-77 days after operation; the wounds of the remaining 55 patients (80.9%) healed in 48-135 days, with an average of 80 days. There was no recurrence of ulcer, peri-osteotomy fracture, or local skin necrosis during follow-up. The serum immunoglobulin levels of 55 patients with wound healing showed that the levels of IgG and IgM decreased significantly on the 3rd and 7th day after operation compared with those before operation (P<0.05), and gradually returned to the levels before operation after 14 days, and reached the peak on the 36th day. IgA levels continued to decrease with time, and there were significant differences at all time points when compared with those before operation (P<0.05). The level of IgE significantly decreased at 21 days after operation compared with that before operation (P<0.05), while it was higher at other time points than that before operation, but the difference was not significant (P>0.05). The level of C3 showed a clear treatment-related increase, which was significantly higher on the 7th, 14th, and 21st days after operation than that before operation (P<0.05), and the peak appeared on the 14th day. The change trend of C4 level was basically synchronous with that of C3, but the amplitude was smaller, and the difference was significant at 7 and 14 days after operation compared with that before operation (P<0.05). There was no significant difference in KAP/LAM between different time points before and after operation (P>0.05). Conclusion TTT can accelerate wound healing, effectively treat diabetic foot ulcer, and reduce amputation rate, and has definite effectiveness. The potential mechanisms of TTT in the treatment of diabetic foot ulcers include the dynamic regulation of IgG, IgA, IgM, and IgE levels to balance the process of inflammation and repair, and the periodic increase of C3 and C4 levels may promote tissue cleaning, angiogenesis, and anti-infection defense.