Pressure-Sensing Insoles in the Neuropathic Ulcer Treatment Pathway

NCT02586519 | Terminated DMC

• 1 other identifier: PINUP
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Diabetes Complications; Neuropathy; Peripheral Neuropathy; Diabetic Foot Ulcer

Keywords

wearable technology; Orpyx; SurroSense Rx; smart insole; TCC; total contact cast; insole; removable cast walker; RCW

Outcome Measures

Primary Outcomes (2)

• Rate of Wound Closure

  Rate of Wound Closure (mm2 per day)

  12 Weeks

• Rate of Wound Resolution

  Rate of Wound Closure (Complete) over first 12 weeks

  12 weeks

Secondary Outcomes (4)

• 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)

Study Arms (3)

Active SurroSense Rx System + RCW

EXPERIMENTAL

Patients randomized to the experimental group will be fitted with an active (alerting) version of the SurroSense R® smart insole System. This device will be placed in the RCW, underneath the liner. The device tab will be fed up the instep, through a hole in the liner, and affixed to the dorsum of the RCW by way of a tie.

Device: SurroSense Rx System

Inactive SurroSense Rx System + RCW

SHAM COMPARATOR

Patients randomized to this group will be fitted with an inactive (non-alerting) version of the device in an identical fashion.

Device: SurroSense Rx System

Inactive SurroSense Rx System + iTCC

SHAM COMPARATOR

Patients in this group will be fitted with an inactive (non-alerting) version of the device in an identical fashion. The RCW will be further secured using a device specific tie such that it acts as an iTCC.

Device: SurroSense Rx System

Interventions

SurroSense Rx System DEVICE

The SurroSense Rx system (Orpyx Medical Technologies Inc., Calgary, AB) is a smart insole system designed to aid in the prevention of plantar pressure ulceration and re-ulceration, and the treatment of active ulcers in neuropathic patients. It comprises two pressure-sensing inserts and a smartwatch display device. The device alerts the user when "safe" pressure and time thresholds have been exceeded so that on-demand offloading can occur.

Also known as: SurroSense Rx Smart Insole System

Active SurroSense Rx System + RCW; Inactive SurroSense Rx System + RCW; Inactive SurroSense Rx System + iTCC

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age \>18
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Zivot Limb Preservation Centre- Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Related Publications (15)

• Cavanagh PR, Bus SA. Off-loading the diabetic foot for ulcer prevention and healing. J Vasc Surg. 2010 Sep;52(3 Suppl):37S-43S. doi: 10.1016/j.jvs.2010.06.007.

  PMID: 20804932 BACKGROUND

• Bus SA, Valk GD, van Deursen RW, Armstrong DG, Caravaggi C, Hlavacek P, Bakker K, Cavanagh PR. The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review. Diabetes Metab Res Rev. 2008 May-Jun;24 Suppl 1:S162-80. doi: 10.1002/dmrr.850.

  PMID: 18442178 BACKGROUND

• Bus SA. Priorities in offloading the diabetic foot. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:54-9. doi: 10.1002/dmrr.2240.

  PMID: 22271724 BACKGROUND

• Lewis J, Lipp A. Pressure-relieving interventions for treating diabetic foot ulcers. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD002302. doi: 10.1002/14651858.CD002302.pub2.

  PMID: 23440787 BACKGROUND

• KOSIAK M. Etiology and pathology of ischemic ulcers. Arch Phys Med Rehabil. 1959 Feb;40(2):62-9. No abstract available.

  PMID: 13618101 BACKGROUND

• Linder-Ganz E, Engelberg S, Scheinowitz M, Gefen A. Pressure-time cell death threshold for albino rat skeletal muscles as related to pressure sore biomechanics. J Biomech. 2006;39(14):2725-32. doi: 10.1016/j.jbiomech.2005.08.010. Epub 2005 Sep 30.

  PMID: 16199045 BACKGROUND

• Reddy M, Gill SS, Rochon PA. Preventing pressure ulcers: a systematic review. JAMA. 2006 Aug 23;296(8):974-84. doi: 10.1001/jama.296.8.974.

  PMID: 16926357 BACKGROUND

• Chawla A, Bhasin G, Chawla R, "Validation Of Neuropathy Symptoms Score (NSS) And Neuropathy Disability Score (NDS ) In The Clinical Diagnosis Of Peripheral Neuropathy In Middle Aged People With Diabetes." The Internet Journal of Family Practice; 12(1).

  BACKGROUND

• Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound classification system. The contribution of depth, infection, and ischemia to risk of amputation. Diabetes Care. 1998 May;21(5):855-9. doi: 10.2337/diacare.21.5.855.

  PMID: 9589255 BACKGROUND

• Lavery LA, Armstrong DG, Harkless LB. Classification of diabetic foot wounds. J Foot Ankle Surg. 1996 Nov-Dec;35(6):528-31. doi: 10.1016/s1067-2516(96)80125-6.

  PMID: 8986890 BACKGROUND

• Mueller MJ, Diamond JE, Sinacore DR, Delitto A, Blair VP 3rd, Drury DA, Rose SJ. Total contact casting in treatment of diabetic plantar ulcers. Controlled clinical trial. Diabetes Care. 1989 Jun;12(6):384-8. doi: 10.2337/diacare.12.6.384.

  PMID: 2659299 BACKGROUND

• Ganguly S, Chakraborty K, Mandal PK, Ballav A, Choudhury S, Bagchi S, Mukherjee S. A comparative study between total contact casting and conventional dressings in the non-surgical management of diabetic plantar foot ulcers. J Indian Med Assoc. 2008 Apr;106(4):237-9, 244.

  PMID: 18828342 BACKGROUND

• Armstrong DG, Lavery LA, Wu S, Boulton AJ. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial. Diabetes Care. 2005 Mar;28(3):551-4. doi: 10.2337/diacare.28.3.551.

  PMID: 15735186 BACKGROUND

• Ahn C, Salcido RS. Advances in wound photography and assessment methods. Adv Skin Wound Care. 2008 Feb;21(2):85-93; quiz 94-5. doi: 10.1097/01.ASW.0000305411.58350.7d.

  PMID: 18349736 BACKGROUND

• Thomas GB, Finney RL. Calculus and Analytic Geometry. 9th ed. Reading, MA: Addison Wesley; 1995.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Complications; Peripheral Nervous System Diseases; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Neuropathies

Study Officials

• Karim Manji, DPM, AACFAS

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer, Department of Surgery, University of Calgary, Cumming School of Medicine, Diabetic Foot & Limb Preservation Centre Peter Lougheed Centre

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 26, 2015
• Study Start: June 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 6, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)