A Superiority Study Comparing Two Pharmaceutical Skin Care Creams Containing Different Humectants with a Non-humectant Containing Skin Care Cream for the Treatment of Xerotic Foot of Persons with Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Xerosis Severity
研究概览
简要总结
Introduction Diabetic foot-ulcers leads to decreased quality of life, risk of major amputation, and resource demanding health-care. To minimize the risk of developing foot-ulcers, persons with diabetes are given the advice to daily inspect their feet and to apply skincare formulations. However, commercially available skincare products have rarely been developed and evaluated for diabetes foot care specifically. The primary aim of this randomized controlled trial (RCT) is to evaluate the effects in reducing foot xerosis in persons with diabetes without foot-ulcers using two skincare creams containing different humectants (interventions) against a cream base non-humectant (comparator). Secondary outcomes are to evaluate differences on skin barrier integrity, low-molecular weight biomarkers and skin microbiota, microcirculation including transcutaneous oxygen pressure, degree of neuropathy, and HbA1c between intervention-comparator cream. Methods Two-armed double-blind RCT. With 80% power, two-tailed significance of 2.5% in each arm, 39 study persons is needed in each arm, total 78 persons, to be able to prove a reduction of at least one category in the Xerosis Severity Scale with the intervention creams compared to the comparator. In one arm, each participant will treat one foot with one of the intervention creams (Oviderm® or Canoderm®), while the opposite foot will be treated with the comparator cream (Decubal® lipid cream®), twice a day. If needed, participants are enrolled after a wash-out period of two weeks. The participants will undergo examinations at baseline, day 14 and day 28. Discussion This RCT evaluate the potential effects of humectants in skin creams against foot xerosis in persons with diabetes. The outcomes of this trial could have implications on treatment recommendations of foot care and for the prevention of foot ulcer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons above 18 years of age diagnosed with diabetes mellitus, both type I and II, with self-experienced dry skin.
- •Dry skin on both feet with a Xerosis Severity Scale (XSS) score between two to six. No more than one XSS score in difference between the subjects' feet.
- •Ability to understand sufficient Swedish language to complete the necessary forms and understand the procedure of the study.
排除标准
- •Known sensibility to any of the ingredients in the products.
- •Other diagnosed skin disease on the feet.
- •Active lesions on either foot.
- •Treatment with local medications, including topical moisturizers or keratolytic agents on the feet, within two weeks before the beginning of the study.
- •Potential study subjects judged unable to comply with treatment schedule and study specific information.
- •Female of childbearing potential that do not use effective medically accepted contraception.
研究组 & 干预措施
Canoderm
Topical on feet twice a day
干预措施: Canoderm (Drug)
Oviderm
Topical on feet twice a day
干预措施: Oviderm (Drug)
Decubal
Topical on feet twice a day
干预措施: Decubal (Drug)
结局指标
主要结局
Xerosis Severity
时间窗: 4 weeks
Change in Xerosis Severity (Scale scores 0 - 6, 6 is the worst)
次要结局
- Transepidermal water loss(4 weeks)
- Skin Capacitance(4 weeks)
- Skin resistance(4 weeks)
- Skin pH(4 weeks)
研究者
Tautgirdas Ruzgas
Professor,Biomedical technology, Study director
Malmö University