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OuYang H, Yang J, Wan H, Huang J, Yin Y. Effects of different treatment measures on the efficacy of diabetic foot ulcers: a network meta-analysis. Front Endocrinol (Lausanne) 2024; 15:1452192. [PMID: 39377075 PMCID: PMC11456420 DOI: 10.3389/fendo.2024.1452192] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/20/2024] [Accepted: 08/29/2024] [Indexed: 10/09/2024] Open
Abstract
Introduction Through a network meta-analysis, we compared different treatment measures for patients with diabetic foot ulcers (DFU), assessing their impact on the healing of DFU and ranking them accordingly. Methods We searched the PubMed, the China National Knowledge Infrastructure (CNKI), Embase, the WanFang and the WeiPu database. The retrieval time was from database establishment to January 2024, and retrieval entailed subject and free words. Randomized controlled trials (RCTs) with different treatment measures for DFU were included. Data extraction and evaluation were based on the PRISMA guidelines. Meta-analyses using pairwise and network methods were employed to compare and rank the effectiveness of different treatments for DFU. Results Ultimately, we included 57 RCTs involving a total of 4,826 patients with DFU. When it comes to ulcer healing rates, compared to standard of care(SOC),platelet-rich plasma(PRP), hyperbaric oxygen therapy(HBOT), topical oxygen therapy(TOT), acellular dermal matrix(ADM), and stem cells(SCs) in both direct meta-analysis(DMA) and network meta-analysis(NMA) can effectively increase the complete healing rate. For Scs+PRP, a statistically significant improvement was only observed in the NMA. Moreover, when compared to the negative pressure wound therapy(NPWT) group, the PRP+NPWT group was more effective in promoting the complete healing of ulcers. In terms of promoting the reduction of ulcer area, no statistical differences were observed among various treatment measures. When it comes to ulcer healing time, both PRP and NPWT can effectively shorten the healing time compared to SOC. Furthermore, when compared to the NPWT group, the combined treatment of PRP and ultrasonic debridement(UD) with NPWT is more effective in reducing healing time. In terms of amputation rates and adverse reactions, the PRP group effectively reduced the amputation rate and adverse reactions for patients with DFU. Additionally, compared to the NPWT group, the combined treatment of PRP and UD with NPWT reduced the incidence of adverse reactions. However, no significant differences were observed among other treatment measures in terms of amputation rates and adverse reactions. The ranking results showed that the efficacy of PRP+NPWT and UD+NPWT in promoting ulcer healing, reducing ulcer area, shortening healing time, decreasing amputation rates and adverse reactions is superior to that of the alone PRP group, NPWT group, and UD group. Conversely, the SOC group demonstrates the least effective performance in all aspects. Conclusion Due to the particularity of the wound of DFU, the standard of care is not effective, but the new treatment scheme has a remarkable effect in many aspects. And the treatment of DFU is not a single choice, combined with a variety of methods often achieve better efficacy, and will not bring more adverse reactions.
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Affiliation(s)
- Hong OuYang
- Geriatric Diseases Institute of Chengdu, Department of Endocrine and Metabolism, Chengdu Fifth People’s Hospital(The Second Clinical Medical College, Affiliated Fifth People’s Hospital of Chengdu University of Traditional Chinese Medicine), Chengdu, China
| | - Jing Yang
- Geriatric Diseases Institute of Chengdu, Department of Endocrine and Metabolism, Chengdu Fifth People’s Hospital(The Second Clinical Medical College, Affiliated Fifth People’s Hospital of Chengdu University of Traditional Chinese Medicine), Chengdu, China
| | - Haiyan Wan
- Geriatric Diseases Institute of Chengdu, Department of Endocrine and Metabolism, Chengdu Fifth People’s Hospital(The Second Clinical Medical College, Affiliated Fifth People’s Hospital of Chengdu University of Traditional Chinese Medicine), Chengdu, China
| | - Jiali Huang
- Geriatric Diseases Institute of Chengdu, Department of Endocrine and Metabolism, Chengdu Fifth People’s Hospital(The Second Clinical Medical College, Affiliated Fifth People’s Hospital of Chengdu University of Traditional Chinese Medicine), Chengdu, China
| | - Yifan Yin
- Department of Nephrology, Chengdu Third People’s hospital, Chengdu, China
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Peng Y, Wang J, Liu X, Zhou Y, Jia S, Xu J, Zheng C. Efficacy of Platelet-Rich Plasma in the Treatment of Diabetic Foot Ulcers: A Systematic Review and Meta-Analysis. Ann Vasc Surg 2024; 98:365-373. [PMID: 37355015 DOI: 10.1016/j.avsg.2023.05.045] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2023] [Revised: 05/22/2023] [Accepted: 05/26/2023] [Indexed: 06/26/2023]
Abstract
BACKGROUND The probiological healing effect of platelet-rich plasma (PRP) during tissue repair has recently gathered much attention. This study aimed to conduct a systematic review and meta-analysis of patients with diabetic foot ulcer (DFU) receiving PRP or conventional treatment to evaluate their efficacy. METHODS PubMed, Excerpta Medica Database (EMBASE), Cochrane Library, and China National Knowledge Infrastructure (CNKI) databases were comprehensively searched by 2 independent reviewers following PRISMA guidelines for the inclusion of randomized controlled trials (RCTs) comparing PRP with conventional treatments for DFUs. The primary measurements of healing rate and healing time, the methodological quality and extracted data were assessed using Review Manager 5.3. Statistical significance was set at P < 0.05. RESULTS A total of 10 RCTs involving 550 patients were included in this study, PRP was observed to significantly improve the healing rate (risk ratio [RR] = 1.38, 95% confidence interval [CI] 1.05-1.82, P = 0.02) and shorten the healing time (mean difference [MD] = -23.23, 95% CI -45.97 to -0.49, P = 0.05) of patients with DFU when compared to the conventional treatment. CONCLUSIONS Compared to conventional treatment, PRP effectively promoted the healing of patients with DFU by evidently improving the healing rate and healing time.
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Affiliation(s)
- Yundong Peng
- School of Sports Medicine and Rehabilitation, Beijing Sport University, Beijing, China
| | - JiePing Wang
- Laboratory of Exercise Biochemistry, Institute of Sports Sciences, University of Taipei, Taipei, Taiwan
| | - Xinyao Liu
- College of Sports Medicine, Wuhan Sports University, Wuhan, China
| | - Yanqing Zhou
- College of Sports Medicine, Wuhan Sports University, Wuhan, China
| | - Shaohui Jia
- Hubei Key Laboratory of Sport Training and Monitoring, College of Sports Medicine, Wuhan Sports University, Wuhan, China
| | - Jinrong Xu
- Hospital of Central China Normal University, Wuhan, China.
| | - Cheng Zheng
- Department of Sports Medicine, Affiliated Hospital, Wuhan Sports University, Wuhan, China.
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Zulbaran-Rojas A, Bara RO, Lee M, Flores-Camargo A, Mishra R, Winocour S, Thompson A, Najafi B. Optimizing Tissue Oxygenation in Reduction Mammoplasty: The Role of Continuous Diffusion of Oxygen: A Feasibility Pilot Randomized Controlled Trial. J Surg Res 2023; 292:113-122. [PMID: 37611440 DOI: 10.1016/j.jss.2023.07.035] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/09/2023] [Revised: 06/05/2023] [Accepted: 07/20/2023] [Indexed: 08/25/2023]
Abstract
INTRODUCTION Bilateral reduction mammoplasty (BRM) aims to alleviate macromastia-related symptoms in women. This procedure involves a T-Junction suture at the medial inframammary fold that encompasses 12%-39% of wound breakdowns mainly due to reduced perfusion. Continuous diffusion of oxygen (CDO) may enhance breast tissue oxygenation to prevent such complication. We explored the feasibility of this therapy. METHODS A 4-wk feasibility-pilot randomized controlled trial of women undergoing BRM was conducted. By internal randomization (left/right side), participants received standard of care (SOC) in one breast using topical skin adhesive, while their other breast received SOC + CDO at the T-junction covered by a silicon sheet (sCDO), or CDO directly to the T-Junction skin (dCDO). Feasibility outcomes included protocol delivery, outcome measurement, device-related adverse events, and device acceptability. Exploratory outcomes were T-Junction SatO2 and deoxyhemoglobin assessed with near-infrared spectroscopy and wound dehiscence. RESULTS Sixteen participants (age = 33 ± 8 y; body mass index = 34.34 ± 5.85 kg/m2) were recruited, conforming n = 32 breasts (SOC, n = 16; dCDO, n = 10, sCDO, n = 6). At 4 wk, protocol delivery was 93.7%, outcome measuring 100%, and device-related adverse events 0%. Device acceptability showed an 85.4% strong agreement for attitude toward use, 78.2% perceived ease of use, and 77.7% perceived usefulness. Breasts undergoing sCDO showed higher SatO2 (P < 0.001), whereas lower deoxyhemoglobin (P < 0.001) compared to all other breast groups. However, wound dehiscence was not different between groups (P = 0.66). CONCLUSIONS Self-applied CDO to the T-Junction is feasible, safe, and acceptable, in patients undergoing BRM. In a proper wound environment, CDO may enhance breast tissue oxygenation. However, it is unclear whether CDO leads to decreased wound dehiscence. This study showed reproducibility for larger randomized trials.
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Affiliation(s)
- Alejandro Zulbaran-Rojas
- Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas
| | - Rasha O Bara
- Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas
| | - Myeounggon Lee
- Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas
| | - Areli Flores-Camargo
- Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas
| | - Ramkinker Mishra
- Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas
| | - Sebastian Winocour
- Division of Adult Plastic Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas
| | - Alastair Thompson
- Section of Breast Surgery, Division of Surgical Oncology, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas
| | - Bijan Najafi
- Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
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Eckert KA, Fife CE, Carter MJ. The Impact of Underlying Conditions on Quality-of-Life Measurement Among Patients with Chronic Wounds, as Measured by Utility Values: A Review with an Additional Study. Adv Wound Care (New Rochelle) 2023; 12:680-695. [PMID: 37815559 PMCID: PMC10615090 DOI: 10.1089/wound.2023.0098] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/28/2023] [Accepted: 08/27/2023] [Indexed: 10/11/2023] Open
Abstract
Significance: Quality of life (QoL) is important to patients with chronic wounds and is rarely formally evaluated. Understanding what comorbidities most affect the individual versus their wounds could be a key metric. Recent Advances: The last 20 years have seen substantial advances in QoL instruments and conversion of patient data to a single value known as the health utilities index (HUI). We review these advances, along with wound-related QoL, and analyze real-world comorbidities challenging wound care. Critical Issues: To understand the impact of underlying comorbidities in a real-world patient population, we examined a convenience sample of 382 patients seen at a hospital-based outpatient wound center. This quality reporting study falls outside the regulations that govern human subject research. Comorbid conditions were used to calculate HUIs using a variety of literature-reported approaches, while Wound-Quality-of-Life (W-QoL) questionnaire data were collected from patients during their first visit. The mean number of conditions per patient was 8; 229 patients (59.9%) had utility values for comorbidities/conditions, which were worse/lower than their wounds' values. Sixty-three (16.5%) patients had depression and/or anxiety, 64 (16.8%) had morbid obesity, and 204 (53.4%) had gait and mobility disorders, all of which could have affected W-QoL scoring. The mean minimum utility value (0.5) was within 0.05 units of an average of 13 studies reporting health utilities from wound care populations using the EuroQol 5 Dimension instrument. Future Directions: The comorbidity associated with the lowest utility value is what might most influence the QoL of patients with chronic wounds. This finding needs further investigation.
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Affiliation(s)
| | - Caroline E. Fife
- Intellicure, LLC, The Woodlands, Texas, USA
- U.S. Wound Registry (501 3C Nonprofit), The Woodlands, Texas, USA
- Baylor College of Medicine, Houston, Texas, USA
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Thanigaimani S, Singh T, Golledge J. Topical oxygen therapy for diabetes-related foot ulcers: A systematic review and meta-analysis. Diabet Med 2021; 38:e14585. [PMID: 33871095 DOI: 10.1111/dme.14585] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/05/2020] [Accepted: 04/12/2021] [Indexed: 01/13/2023]
Abstract
INTRODUCTION Topical oxygen therapy (TOT) has been suggested as a treatment for diabetes-related foot ulcer (DFU) but no prior meta-analyses of randomised clinical trials (RCT) have been reported. This systematic review and meta-analysis examined the randomised evidence for the benefit of TOT in healing DFU. METHODS Publicly available databases were searched for RCTs investigating the effect of TOT on wound healing in participants with a DFU. The primary outcome was ulcer healing defined as full epithelialisation. Meta-analyses were performed using random effect models and reported as risk ratios (RR) and 95% confidence intervals (CI). Study quality and publication bias were assessed using a modified version of the Cochrane Collaboration's tool and funnel plots, respectively. RESULTS Six RCTs involving 530 participants with a DFU testing TOT were included. Meta-analysis suggested that TOT significantly increased the likelihood of ulcer healing compared to controls (Risk ratio [RR] 1.94; 95% CI 1.19, 3.17; I2 = 57%; NNT = 5.33) and findings were robust in sensitivity analyses. Risk of bias was high, moderate and low in two, one and three studies, respectively. Analysis of the three trials judged to be at low risk of bias suggested that TOT increased the likelihood of ulcer healing compared to controls (RR 2.37; 95% CI 1.52, 3.68; I2 = 0%). Funnel plots suggested the possibility of publication bias. Data on amputation were too limited for meta-analysis. CONCLUSION This meta-analysis suggests that TOT improves the likelihood of DFU healing; however, its effect on amputation and cost-effectiveness are unclear.
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Affiliation(s)
- Shivshankar Thanigaimani
- The Queensland Research Centre for Peripheral Vascular Disease (QRC-PVD), College of Medicine and Dentistry, James Cook University, Queensland, Australia
- The Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia
| | - Tejas Singh
- The Queensland Research Centre for Peripheral Vascular Disease (QRC-PVD), College of Medicine and Dentistry, James Cook University, Queensland, Australia
- The Department of Vascular and Endovascular Surgery, The Townsville University Hospital, Townsville, Queensland, Australia
| | - Jonathan Golledge
- The Queensland Research Centre for Peripheral Vascular Disease (QRC-PVD), College of Medicine and Dentistry, James Cook University, Queensland, Australia
- The Australian Institute of Tropical Health and Medicine, James Cook University, Townsville, Queensland, Australia
- The Department of Vascular and Endovascular Surgery, The Townsville University Hospital, Townsville, Queensland, Australia
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Chan BC, Campbell KE. An economic evaluation examining the cost-effectiveness of continuous diffusion of oxygen therapy for individuals with diabetic foot ulcers. Int Wound J 2020; 17:1791-1808. [PMID: 33189100 PMCID: PMC7754389 DOI: 10.1111/iwj.13468] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/05/2020] [Revised: 07/02/2020] [Accepted: 07/07/2020] [Indexed: 01/02/2023] Open
Abstract
Continuous delivery of oxygen therapy has been observed to improve healing for individuals with an advanced diabetic foot ulcer (DFU). However, this intervention requires the purchasing of an oxygen delivery device and moist dressings. It is unknown whether this upfront financial investment represents good value for money. Thus the aim of this project is to evaluate the cost-effectiveness of treating advanced DFU using continuous delivery of oxygen compared with negative pressure wound therapy from the perspective of the public health care payer in Ontario, Canada. A microsimulation model was constructed with inputs from peer-reviewed journal publications and publicly available reports. The 5-year costs and quality-adjusted life-years were compared between treatment and comparator. Sensitivity analyses were conducted to evaluate the robustness of results. The model predicted that continuous delivery of oxygen would cost $4800 less compared with negative pressure wound therapy and increased quality-adjusted life years by 0.025. Lower cost and improved outcomes were observed in most scenario analyses. The results of this economic evaluation suggest that CDO therapy may reduce health care economic burden with a modest increase in quality of life outcomes. Health care decision-makers should consider the inclusion of CDO for the treatment of DFU.
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Affiliation(s)
- Brian C.‐F. Chan
- KITE – Toronto Rehabilitation InstituteUniversity Health NetworkTorontoCanada
- Institute of Health Policy, Management and EvaluationUniversity of TorontoTorontoCanada
| | - Karen E. Campbell
- School of Physical Therapy, Faculty of Health ScienceWestern UniversityLondonCanada
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