Evidence map›Paper›PMID 37533132›Full record

ArticleTrials2023

Efficacy and safety of pentoxifylline for chronic venous leg ulcers: study protocol for a multicenter randomized controlled trial in China (ESPECT study).

Lihong Chen, Yun Gao, Ming Liu, Qiu Li, Chunmao Han, Yue Zhao, Binghui Li, Jun Xu, Yan Dai, Pei Li and 3 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 1 country.

Lihong Chen *Innovation Center for Wound Repair, Diabetic Foot Care Center, Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, 37 Guo Xue Lane, Chengdu, 610041, China.
Yun Gao *Innovation Center for Wound Repair, Diabetic Foot Care Center, Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, 37 Guo Xue Lane, Chengdu, 610041, China.
Ming LiuDepartment of Peripheral Vascular Disease, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250014, China.
Qiu LiDepartment of Endocrinology, Shandong Provincial Hospital, Jinan, 250021, China.
Chunmao HanDepartment of Burn and Wound Repair, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, 310009, China.
Yue ZhaoDepartment of Vascular Surgery, China-Japan Union Hospital of Jilin University, Changchun, 130033, China.
Binghui LiDepartment of Wound Repair, LiYuan Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430077, China.
Jun XuDepartment of Diabetic Podiatry, Zhu Xianyi Memorial Hospital of Tianjin Medical University, Tianjin, 300070, China.
Yan DaiInnovation Center for Wound Repair, Diabetic Foot Care Center, Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, 37 Guo Xue Lane, Chengdu, 610041, China.
Pei LiCSPC Ouyi Pharmaceutical Co., Ltd., Shijiazhuang, 052160, China.
Jianli LiCSPC Ouyi Pharmaceutical Co., Ltd., Shijiazhuang, 052160, China.
Yuanyuan LiCSPC Ouyi Pharmaceutical Co., Ltd., Shijiazhuang, 052160, China.
Xingwu RanInnovation Center for Wound Repair, Diabetic Foot Care Center, Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, 37 Guo Xue Lane, Chengdu, 610041, China. ranxingwu@163.com.ORCID http://orcid.org/0000-0002-6634-1241
Sichuan University · CNShijiazhuang Yiling Pharmaceutical (China) · CNAffiliated Hospital of Shandong University of Traditional Chinese Medicine · CNHuazhong University of Science and Technology · CNSecond Affiliated Hospital of Zhejiang University · CNShandong Provincial Hospital · CNTianjin Medical University · CNUnion Hospital · CN

Funding

Science and Technology Bureau of Sichuan Province 2021JDKP004West China Hospital, Sichuan University ZYGD18025
6 · The paper itself

Abstract

backgroundVenous leg ulcers (VLUs) are the most severe manifestation of chronic venous disease, with long healing time and a high recurrence rate. It imposes a heavy burden on patients, their families, and the health care system. Chronic inflammation triggered by sustained venous hypertension is now recognized as the hallmark of chronic venous disease. The anti-inflammatory effect of pentoxifylline may offer a promising avenue to treat VLUs. However, current evidence of pentoxifylline for VLUs is relatively small and of low quality. The aim of this study is to evaluate the efficacy and safety of pentoxifylline for VLUs in the Chinese population.

methodsThis is a randomized, double-blinded, double-dummy, multi-center, placebo-controlled clinical trial. A total of 240 patients will be randomized to receive pentoxifylline (400 mg, twice daily) or placebo for 24 weeks. All participants will receive diosmin treatment and standard care of VLUs and other comorbidities. The primary outcome is the difference in the wound healing rate within 12 weeks between pentoxifylline and placebo. Secondary outcomes include (1) percent wound size changes at 12 weeks, (2) the levels of TNF-α and IL-6, (3) venous clinical severity score and chronic venous insufficiency quality of life score, and (4) ulcer recurrence within 24 weeks. DISCUSSION: This study would evaluate the efficacy and safety of pentoxifylline for VLUs in the Chinese population. If confirmed, it wound offer another effective and safe therapeutic option for treatment of VLUs.

trial registrationThe trial was registered at the Chinese Clinical Trial Registry (No. ChiCTR-2100053053). Registered on 10 November, 2021, https://www.chictr.org.cn/showproj.aspx?proj=137010.

Indexed as

Leg UlcerPentoxifyllineVaricose UlcerVenous InsufficiencyHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicWound HealingPentoxifyllineChronic woundsPentoxifyllineVenous leg ulcersWound and injuriesWound healing

Identifiers

PMID37533132
PMCPMC10394857
OpenAlexW4385494001

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.