Remote Monitoring of Healed Diabetic Foot Ulcers With Podimetrics Temperature Monitoring System for Prevention of Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 6
- 主要终点
- rate of diabetic foot ulcer recurrence in during phase of trial
研究概览
简要总结
One of the only evidence-based practices for the prevention of diabetic foot ulcer recurrence is once-daily foot temperature monitoring, which is recommended by multiple clinical practice guidelines for high-risk patients, including those with history of foot ulcers. The purpose of this research study is to evaluate the use of once-daily foot temperature monitoring to reduce the occurrence and recurrence of diabetic foot ulcers and reduce total health care utilization for diabetic patients with a foot ulcer that has healed in the past 24 months.
详细描述
Skin temperature monitoring as a useful tool to detect tissue at risk for breakdown and ulceration first emerged in the 1970s and has been examined by several investigators. For neuropathic wounds (excluding acute injury) the hypothesized mechanism is believed to be repetitive stress and micro-trauma leading to enzymatic autolysis of tissue, inflammation, and a resulting measurable increase in local skin temperature.
In 1997, a paper was published examining 143 consecutive patients presenting to the University of Texas' High Risk Diabetic Foot Clinic. They hypothesized that individuals with acute pathology would show an increase in skin temperature when comparing the affected foot to the contralateral unaffected foot. Mean delta-temperatures for neuropathic ulcers and Charcot arthropathy were found to be 5.6°F (n=44, p<0.0001) and 8.3°F (n=21, p<0.0001), respectively. No statistical difference was found in neuropathic participants without acute pathology (n=78).
In a project funded by the National Institute of Health, the same investigators conducted a series of studies, published between 2004 and 2007, examining the impact of self-assessed dermal thermometry in high-risk diabetic patients In the first randomized controlled trial in 2004, 85 patients were assigned to one of two groups, Usual Therapy or Enhanced Therapy.
Participants were eligible if they had either a history of foot ulceration or lower extremity amputation, or if they had moderate to severe peripheral sensory neuropathy with a foot deformity. Both groups received therapeutic footwear, diabetic education, and regular foot evaluation by a podiatrist. Enhanced Therapy participants additionally received a hand-held dermal thermometer to self-record dermal temperatures at six sites on each foot, twice per day. If a delta-temperature between any two corresponding sites was found to be greater than 4 F, participants were instructed to reduce activity and contact the study nurse. After six months of follow-up, Enhanced Therapy participants experienced significantly fewer foot ulcerations and Charcot fractures (2% vs. 20%, p=0.01) than the Usual Therapy group. The study was blinded to physician only. A limitation of the study was the difficulty in determining whether the Enhanced Therapy group received greater attention by the care team, and therefore better monitoring and therapy.
In their second randomized controlled trial conducted in 2007, 173 participants were enrolled between the Texas A&M University Health Science Center and the Rosalind Franklin University of Medicine and Science. Participants were eligible if they were diabetic and had a history of previous foot ulcer, and were assigned to one of three groups: Standardized Therapy, Structured Foot Exam, and Enhanced Therapy. All three groups received standard of care (therapeutic footwear, diabetic foot education, and regular foot evaluation by a podiatrist) and were instructed to contact the study nurse if they noticed any abnormalities during their daily foot inspection. The Structured Foot Exam group, in addition to standard training, were instructed to conduct a structured foot inspection twice daily with the assistance of a mirror and record any noted changes in color, swelling or warmth in a detailed log book. The Enhanced Therapy group, in addition to standard training, were trained to use a hand-held dermal thermometer to record daily foot temperatures at the six locations on each foot, noting any delta-temperatures between feet. Should a difference between corresponding sites be found greater than 4 degF for two consecutive days, participants were instructed to contact the study nurse and decrease activity until temperatures normalized. After 15 months of follow-up, Enhanced Therapy participants had fewer foot ulcers than Standard Therapy participants and Structured Foot Examination participants (Enhanced Therapy 8.5% vs. Standard Therapy 29.3%, p=0.0046; and Enhanced Therapy 8.5% vs. Structured Foot Examination 30.4%, p=0.0029). No difference was found between Standard Therapy and Structured Foot Exam groups. The study was physician blinded as before.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •a diagnosis of diabetes mellitus (type 1 or 2)
- •a history of diabetic foot ulcer or amputation which healed within the 24 months prior to enrollment
- •adequate lower extremity vascular supply, defined as presence of palpable bilateral posterior tibial and dorsalis pedis pulses or an ankle brachial index exceeding 0.5 documented within the 12 months preceding study enrollment
- •the ability to provide informed consent
排除标准
- •baseline inflammatory foot conditions, including unhealed ulcer or lesion (dorsal or plantar), active Charcot arthropathy, ongoing foot infection, or ongoing cellulitis
- •a history of amputation more proximal than a transmetatarsal amputation in either foot
- •inability to ambulate without the assistance of a wheelchair, walker, or crutches
- •travel plans expected to interrupt the use of the study device for longer than two consecutive weeks
- •any condition which, in the investigator's judgment, rendered the patient unsuitable or unreliable for participation.
结局指标
主要结局
rate of diabetic foot ulcer recurrence in during phase of trial
时间窗: From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial
temporal rate of new diabetic foot ulcers occurring to participants (total number of diabetic foot ulcers divided by the total exposure duration for the participants)
rate of diabetic foot ulcer recurrence in after phase of trial
时间窗: From completing use of the study device until the analysis date on Jan 1, 2020 (between six months and three years on average for participants), exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial
temporal rate of new diabetic foot ulcers occurring to participants (total number of diabetic foot ulcers divided by the total exposure duration for the participants)
rate of diabetic foot ulcer recurrence in before phase of trial
时间窗: From two years before the date of enrollment until the date of enrollment, exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial
temporal rate of new diabetic foot ulcers occurring to participants (total number of diabetic foot ulcers divided by the total exposure duration for the participants)
次要结局
- rate of lower extremity amputations in before phase of trial(From two years before the date of enrollment until the date of enrollment, exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial)
- rate of lower extremity amputations in during phase of trial(From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial)
- rate of severe diabetic foot ulcer recurrence in during phase of trial(From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial)
- adherence in daily use of the study device(From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial)
- rate of inflammation episodes detected by the study device(From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial)
- rate of outpatient visits in after phase of trial(From completing use of the study device until the analysis date on Jan 1, 2020 (between six months and three years on average for participants), exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial)
- rate of severe diabetic foot ulcer recurrence in before phase of trial(From two years before the date of enrollment until the date of enrollment, exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial)
- rate of severe diabetic foot ulcer recurrence in after phase of trial(From completing use of the study device until the analysis date on Jan 1, 2020 (between six months and three years on average for participants), exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial)
- rate of inpatient admissions in after phase of trial(From completing use of the study device until the analysis date on Jan 1, 2020 (between six months and three years on average for participants), exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial)
- rate of inpatient admissions in before phase of trial(From two years before the date of enrollment until the date of enrollment, exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial)
- rate of inpatient admissions in during phase of trial(From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial)
- rate of outpatient visits in before phase of trial(From two years before the date of enrollment until the date of enrollment, exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial)
- rate of lower extremity amputations in after phase of trial(From completing use of the study device until the analysis date on Jan 1, 2020 (between six months and three years on average for participants), exclusive of periods when the participant was not a beneficiary of the health plan sponsoring the trial)
- rate of outpatient visits in during phase of trial(From the date of enrollment until the participant completed one year using the study device, or until withdrawing consent, dropping out, dying, or disenrolling as a beneficiary of the health plan sponsoring the trial)