Topical Esmolol Hydrochloride as a Novel Treatment Modality for Diabetic Foot Ulcers: A Phase 3 Randomized Clinical Trial.

Importance: Preclinical and phase 1/2 studies with esmolol hydrochloride suggest its potential role in treatment of diabetic foot ulcers (DFUs). Objective: To study the efficacy of topical esmolol for healing of uninfected DFUs. Design, Setting, and Participants: A randomized, double-blind, multicenter, phase 3 clinical trial was conducted from December 26, 2018, to August 19, 2020, at 27 referral centers across India. Participants included adults with DFUs. Interventions: Participants were randomized after a run-in phase (1 week) to receive esmolol, 14%, gel with standard of care (SoC), SoC only, or vehicle with SoC (3:3:1 proportion) for 12 weeks (treatment phase) and followed up subsequently until week 24. Main Outcomes and Measures: The primary outcome was the proportion of wound closure within the 12-week treatment phase in the esmolol with SoC and SoC only groups. Analysis was conducted using an intention-to-treat safety evaluable population, full analysis set or efficacy-evaluable population, and per-protocol population comparing the esmolol plus SoC and SoC only treatment groups. Results: In the study, 176 participants (122 men [69.3%]; mean [SD] age, 56.4 [9.0] years; mean [SD] hemoglobin A1c level, 8.6% [1.6%]) with DFUs classified as University of Texas Diabetic Wound Classification system grade IA and IC (mean [SD] ulcer area, 4.7 [2.9] cm2) were randomized to the 3 groups. A total of 140 participants were analyzed for efficacy. The proportion of participants in the esmolol with SoC group who achieved target ulcer closure within 12 weeks was 41 of 68 (60.3%) compared with 30 of 72 (41.7%) participants in the SoC only group (odds ratio [OR], 2.13; 95% CI, 1.08-4.17; P = .03). A total of 120 participants completed the end of study visit which were analyzed. Target ulcer closure by the end of the study (week 24) was achieved in 44 of 57 (77.2%) participants in the esmolol with SoC group and 35 of 63 (55.6%) participants in the SoC only group (OR, 2.71; 95% CI, 1.22-5.99; P = .01). The median time for ulcer closure was 85 days for the esmolol with SoC group and was not estimable for SoC only group. Significant benefits of Esmolol with SoC were seen in patients with factors that impede the healing of DFU. Treatment-emergent adverse events were noted in 18.8% of the participants, but most (87.3%) of these events were not attributable to the study drug. Conclusions and Relevance: In this multicenter, randomized, double-blind clinical trial, the addition of esmolol to SoC was shown to significantly improve the healing of DFUs. With these results, topical esmolol may be an appropriate addition to SoC for treating DFUs. Trial Registration: ClinicalTrials.gov Identifier: NCT03998436; Clinical Trial Registry, India CRI Number: CTRI/2018/11/016295.

A comparative study of Desarda's technique with Lichtenstein mesh repair in treatment of inguinal hernia: A prospective cohort study.

BACKGROUND: The Desarda repair technique of inguinal hernia repair introduced in 2001 is still not considered standard tissue based hernia repair technique. We compared the tissue based Desarda technique with standard Lichtenstein repair in treatment of primary inguinal hernia. METHODS: 187 cases were allocated into 2 groups. Desarda (D Group) had 92 and Lichtenstein (L Group) had 95 patients. Primary outcome factor was early (<1 year) recurrence of inguinal hernia. Secondary outcome factors included operative time measured from skin incision to skin closure. Postoperative pain scores was assessed on day 1, 3, 7, 30 and 90 using Visual analogue scale. Time taken to return to basic and home activities was calculated. Cord oedema, groin discomfort, seroma, fever, surgical site infections, chronic pain, etc. were evaluated as postoperative complications. RESULTS: After a 15-month mean follow up period 1 recurrence is noted in each arm (P = 1). Operative time was 73.89 ± 12.63 min in Lichtenstein and 72.60 ± 13.89 min in desarda repair (P = 0.508). Postoperative pain was significantly less in the first 7 post-operative days in Desarda group (P = 0.09) compared to Lichtenstein group. Time taken to return to basic and home activities was significantly less in Desarda group (P = 0.001). There was no statistical difference in rates of post-operative complications among the two arms of the study. CONCLUSION: The results of inguinal hernia treatment with the Desarda technique are similar to the results after standard Lichtenstein operations. Desarda technique does not use a mesh. Patients after Desarda's operative procedure get ambulatory sooner as compared to the standard Lichtenstein mesh repair. Less Postoperative pain, complications similar to standardised technique. Desarda technique has the potential to enlarge the number of tissue based methods available to treat groin hernias.

Scalp actinomycosis presenting as soft tissue tumour: A case report with literature review.

INTRODUCTION: Actinomycosis is a rare subacute or chronic bacterial infection caused by Gram positive, anaerobic or microaerophilic bacilli. It is characterized by suppuration, abscess formation, tissue fibrosis, draining sinuses & rarely as a soft tissue mass mimicking a tumor. CASE REPORT: A 16 year old boy sustained a trauma over right forehead & wound after which patient presented with swelling over right forehead which was excised and was histopathologically reported as angiomatous lesion. Patient presented with recurrent swelling with ulceration over the same site. CT scan showed soft tissue mass with periosteal reaction of right frontal bone. Wide local excision with removal of periosteum was carried out. Raw area was covered with rotational scalp flap. Histopathology of the excised specimen showed features of actinomycosis. DISCUSSION: Cutaneous actinomycosis presenting as pseudocarcinomatous or sarcomatous mass is rare. Trauma is a common preceding event which was observed in present case. Histopathological confirmation is mandatory with visualization of sulfur granules. It is managed by high dose IV antibiotics. Surgical resection is a useful adjuvant therapy specially in large, disfiguring masses not responding to medical treatment and where excisional biopsy is helpful in establishing the diagnosis surgical excision alone is not curative, post operative long term antibiotics are adjuvant therapy to avoid recurrence. CONCLUSION: Actinomycosis of scalp skin is a rare entity and tumor like presentation is still uncommon. Lesions not resolving with routine antibiotics therapy should be suspected clinically as actinomycosis and treated with high dose antibiotics as histopathology from small biopsy is unreliable.

Dhoti cancer: a waistline skin cancer with review of literature.

Skin cancers account for less than 1 % of all malignancies in India. Squamous cell carcinomas occurring over the waistline due to tying of cotton cloth called dhoti in males and sarees in females are predominantly seen in traditional Indian population. On wearing of these clothes for years, there is a constant irritation which produces depigmentation, glazing of the skin, acanthosis, scar formation, and later on malignant transformation. Presenting a case of a 65-year-old male with 7 × 5 cm ulceroproliferative growth over the right waistline with a history of prolonged use of dhoti. Wide local excision of the growth with 2-cm margin and primary closure of wound by mobilizing the skin was carried out. Histopathology showed well-differentiated squamous cell carcinoma. The patient is clinically disease free after postoperative follow-up of 1 year.

Triple negative breast cancer: an Indian perspective.

INTRODUCTION: Breast cancer is the most common female cancer in the world. Triple negative breast cancer (TNBC) is a recently identified biological variant with aggressive tumor behavior and poor prognosis. Data of hormonal status from the Indian population is scarce due to financial constraints in performing immunohistochemistry evaluation. The present study aims to prospectively analyze receptor status of all breast cancer patients and identify TNBC and compare their clinical profile and short term survival with other non-TNBC group. MATERIALS AND METHODS: All cytologically and histopathologically confirmed cases of carcinoma breast were prospectively enrolled. In a longitudinal study at tertiary care hospital in central India based on the hormonal status, they were further divided into TNBC and other groups. Comparison of risk factors, clinical profile and short-term survival was carried out. RESULTS: A total 85 patients were enrolled and of them 37 (43.7%) were TNBC. On comparing risk factors ie, age, age at menarche, total reproductive age, age at first child birth, and menopausal status - no statistical significance was observed between the TNBC and non-TNBC groups. But on comparison of clinical profile TNBC tumors were significantly large with majority of patients presenting as locally advanced breast cancer (83%). No statistical difference was observed in axillary lymph node status between two groups. TNBC tumors were histologically more aggressive (grade 3) compared to other groups. No statistically significant difference was observed in short term overall survival but all three deaths were observed in the TNBC group only and two local recurrences after surgery were observed in the TNBC group. CONCLUSION: TNBC forms a large proportion of carcinoma breast patients in a central Indian scenario and needs more research to identify appropriate treatment planning considering aggressive histology and advanced presentation.

Effects of yoga on functional capacity and well being.

Yoga has proven beneficial effects on various health domains including musculoskeletal conditions, cardiopulmonary conditions through the practice of asana and pranayamas as well as on mental health, as it is known to enhance the body-and mind coordination. There is paucity of data on the effect of yoga on functional capacity in literature using 6 min walk test. The present study aims to look at the effect of yoga on 6-min walked distance, rating of perceived exertion (RPE), recovery time following the walk and state of well being. This is a hospital-based longitudinal study where 30 physiotherapy students of the age group 18 - 22 years of either sex were enrolled. Subjects having musculoskeletal problems, cardio respiratory disease and those who were not willing to volunteer were excluded They received Yoga intervention in form of Yogic practices which included a combination of asanas, pranayamas and omkar chanting for 1 h for 30 sessions. A baseline 6-min walk test was conducted on subjects and the 6-min walked distance, rating of perceived exertion (RPE) on modified Borg's scale were recorded. The baseline state of well-being was noted using the Warwick- Edinburgh mental well-being scale and similar recording was done post intervention after 30 sessions. Of the 30 subjects, there were no drop outs as these were committed college students. Of them, 24 were females and 6 were males with a mean age of 21.5 years SD 2.38. Statistically significant improvements were observed in 6-min walk distance (P value = 0.000), RPE (P value < 0.000), recovery time (P value < 0.000) and sense of well being score (P value < 0.000). Yoga practices are beneficial in improving the functional capacity in young healthy adults. Yoga can very well be incorporated in medical practice for increasing the patient's functional capacity, for those who have limitations in performing aerobic training due to various health reasons. The improved state of well being motivates the patients to adhere to yogic practices.

Case of unusual foreign body in the rectum.

A 44-year-old male patient with a foreign body in rectum (beverage bottle), introduced as sexual perversion, is presented with literature review. The management emphasis is on transanal retrieval and ruling out of the rectal and colonic perforation and the requirement for postremoval psychiatric treatment.

Attitudes of developing world physicians to where medical research is performed and reported.

BACKGROUND: Little is known about the influence of the site of research or publication on the impact of the research findings on clinical practice, particularly in developing countries. The International Clinical Epidemiology Network (INCLEN) is dedicated to improving the quality of health research in the Developing World through institutional capacity building for evidence based medicine, and provided the opportunity to examine the likely impact of research location and journal location on physicians' practice in a number of the participating countries. METHODS: Physicians from secondary and tertiary hospitals in six cities located in China, Thailand, India, Egypt and Kenya were enrolled in a cross-sectional questionnaire survey. The primary outcome measures were scores on a Likert scale reflecting stated likelihood of changing clinical practice depending on the source of the research or its publication. RESULTS: Overall, local research and publications were most likely to effect change in clinical practice, followed by North American, European and regional research/publications respectively, although there were significant variations between countries. The impact of local and regional research would be greater if the perceived research quality improved in those settings. CONCLUSION: Conducting high quality local research is likely to be an effective way of getting research findings into practice in developing countries.