Pressure-Sensing Insoles in the Neuropathic Ulcer Treatment Pathway (PINUP): A Randomized Controlled Trial for Active Neuropathic Ulcer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Rate of Wound Closure
研究概览
简要总结
Diabetic foot ulceration (DFU) is a common complication with a 25% lifetime risk in patients with diabetes. While most of these ulcers can be treated successfully on an outpatient basis, some will persist and become infected. Nearly one fifth of patients with lower-extremity diabetic ulcers will require amputation of the affected limb, resulting in staggering costs for both the patient and the healthcare system. Therapies that promote rapid and complete healing and reduce the need for expensive surgical procedures impact these costs substantially.
The standard of care for the treatment of diabetic foot ulcers is the removable cast walker (RCW). RCW use has demonstrated plantar pressure reduction yet is typically perceived as having compliance issues due to its removable nature. In addressing this limitation, a modified version of the RCW has been developed by wrapping it in a layer of cohesive or plaster bandage. This technique has been termed the "instant" total contact cast (iTCC) derived from the seldom-used, gold standard treatment, the total contact cast (TCC). While ease of application and potential clinical equivalence are clear benefits, the iTCC carries disadvantages on account of its irremovability. For example, frequent dressing changes impractical, yet may be necessary for complex wound care. The goal of this research is to continue inquiry and innovation in this most basic aspect of care, whilst addressing the limitations of past research and failures in this domain.
The investigators propose examining the capability of the SurroSense Rx® smart insole and smartwatch system (Orpyx Medical Technologies Inc., Calgary AB) in managing and monitoring adherence to plantar pressure offloading through alert-based feedback. The insoles are embedded with pressure sensors, which wirelessly communicate with a smartwatch that provides feedback on modifying activity or pressure profile over time. This smartwatch transmits audio, visual, and tactile notifications when excessive pressure-time thresholds under plantar regions of interest have been met. This feedback allows patients to be educated on their plantar pressure, and engages them and their caregivers to manage adherence to offloading. The investigators also propose comparing the healing rates of active neuropathic ulcers using RCWs coupled with the SurroSense Rx® smart insole system to assess whether adjunctive use of the two interventions improves the efficiency of neuropathic ulcer treatment.
详细描述
Pressure offloading is the lynchpin of neuropathic ulcer care. Multiple methods of statically reducing pressure have been employed, with various degrees of success, in the ulcer care continuum. Traditional offloading interventions redistribute the load on the plantar surface, and include: non-removable devices (total contact casts, removable walkers rendered non-removable, and cast shoes), and removable devices (walkers, forefoot offloading shoes, half shoes, bivalve total contact casts, and therapeutic shoes)1,2,3.
A Cochrane Review on the use of offloading in the treatment of uncomplicated neuropathic plantar ulcers gives the efficacy of each device type in terms of percentage of ulcers healed and time required for healing4. The total contact cast has been found to be more effective than removable devices in many randomized controlled trials, for both the percentage of neuropathic ulcers healed and the time required for healing5,6,7. Ninety-two percent of neuropathic ulcers healed in an average of 6 weeks8. Removable walkers made non-removable may be as effective as total contact casts9,10,11. The effectiveness of forefoot offloading shoes, half-shoes, and cast shoes in the healing of neuropathic forefoot ulcers needs to be confirmed by prospective trials12. The lower efficacy of prescribed removable devices could be attributable to a lower adherence to recommended use13.
The effectiveness of offloading interventions is intimately linked to the skin reperfusion that is seen when persistent external pressure is alleviated. Key modifiable parameters in mitigating tissue damage to the neuropathic foot are pressure and time. Kosiak reported in 1959 that "microscopic pathologic changes were noted in tissues subjected to as little as 60 mmHg for only one hour"14,15. More recently, exposures from 15 min to one hour at pressures greater than 240 mmHg, and from two hours or more at pressures greater than 67 mmHg, were found to cause cell death in rat muscle tissue16. Despite this, there is limited information regarding the efficacy of interventions aimed at preventing pressure ulcers; a comprehensive review of the literature did not find enough evidence to recommend a repositioning frequency17. A consensus document from an international review on pressure ulcer prevention states that "patients confined to wheelchairs should be taught to reposition every 15 minutes"18.
While established pressure offloading interventions are able to statically reduce pressure on the active ulcer, they provide no dynamic relief of pressure. Since neuropathy is characterized by a loss of protective sensation (LOPS), the patient is often unaware of sustained pressure on a specific anatomic region over time. Even with static offloading instruments, it is conceivable that critical pressure and time thresholds can be dynamically exceeded without the patient's knowledge or ability to address the problem.
Taken together, the literature provides support for the development of a system that monitors pressure over time at key locations, and provides alert-based feedback to guide as-needed, patient-based offloading for use in patients with active ulceration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes (according to AAFP diagnostic criteria )
- •Presence of neuropathy with Loss of Protective Sensation (LOPS), as defined by any loss of sensation as per the assessments included in the Modified Neuropathy Disability Score (MNDS)
- •Active plantar diabetic foot ulcer (Grade 1A, according to the University of Texas Wound Classification System , )
- •A minimum size ulcer ≥0.5cm2 and ≤ 12 cm2 post debridement at time of randomization
- •If the subject has more than one ulcer, they should be identified and at least 2 cm apart
- •At least one palpable foot pulse
- •Ability to understand all of the study requirements
- •Life expectancy greater than the duration of the study
- •Subject or responsible caregiver is willing and able to maintain the required offloading (as applicable for the location of the ulcer) and applicable dressing changes
- •Doppler Ultrasound positive for at least one pedal pulse in each foot
排除标准
- •Weight > 400 lb (182 kg)
- •Uncorrected visual impairment
- •Active Infection
- •Non-plantar ulcers on the ankle, posterior heel, or other location
- •More than one active plantar ulcer
- •Presence of severe ischemia (any of: absence of foot pulses, Ankle Brachial Index 0.6 > [ABI] > 1.2, capillary refill time > 5 seconds; see Appendix 3)
- •Current participation in another clinical investigation of a medical device or a drug; or has participated in such a study within 30 days prior to this study
- •Current smokers
- •Active abuse of alcohol
- •o Subject has a history of any of the following intercurrent illnesses or conditions that would compromise the safety of the subject or the normal healing process:
- •End-stage renal disease
- •Immunosuppression
- •Severe malnutrition
- •Liver disease
- •Aplastic anemia
- •Scleroderma
- •Acquired immune deficiency disease (AIDS) or HIV positive
- •Connective tissue disorder
- •Exacerbation of sickle cell anemia
- •Active Charcot foot
- •Excessive lymphedema
- •Osteomyelitis and gangrene
- •Subjects with ulcers secondary to a disease other than diabetes (e.g. vasculitis, neoplasms or haematological disorders)
- •o At the end of the run-in period and prior to randomization, the subject be excluded if the following conditions are not met:
- •Subject does not continue to meet the entrance criteria (inclusion and exclusion)
- •The size of the study ulcer, following debridement, has decreased by more than 30% from the baseline assessment measured at screening.
- •Abnormal toe and/or ankle range of motion
结局指标
主要结局
Rate of Wound Closure
时间窗: 12 Weeks
Rate of Wound Closure (mm2 per day)
Rate of Wound Resolution
时间窗: 12 weeks
Rate of Wound Closure (Complete) over first 12 weeks
次要结局
- Recurrence of Ulcer(6 months)
- Cost Utility(Wound Healing Period (up to 12 weeks) + 6 Months Post-Wound Closure)
- Activity(Wound Healing Period (up to 12 weeks) + 6 Months Post-Wound Closure)
- Complication Rates(Wound Healing Period (up to 12 weeks))
研究者
Dr. Karim Manji
Clinical Lecturer, Department of Surgery, University of Calgary, Cumming School of Medicine, Diabetic Foot & Limb Preservation Centre Peter Lougheed Centre
University of Calgary