Evaluating Plantar Foot Pressure in a Novel Diabetic Offloading Device

Diabetic Foot Ulcer Clinical Trial

Official title:

Does a Novel Diabetic Foot Offloading Boot Reduce the Pressure Time Integral Compared to Usual Standard Care, in Patients With Diabetic Foot Ulcer? A Proof of Concept Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336176
• Other study ID #: 17/NS/0027
• Status: Completed
• Phase: N/A
• Start date: March 22, 2018
• Est. completion date: July 29, 2018

Study information

• Verified date: April 2020
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The impacts from diabetes are both patient related and healthcare based. Offloading is recognised as the priority treatment for healing neuropathic and neuro-ischaemic plantar foot ulcers. The new PulseFlow DF boot is a device which claims to off load but has little or no evidence on diabetic foot ulcer (DFU) subjects. Thus the primary aim of this study is to observe forefoot plantar pressures in a cross sectional purposively selected sample compared to usual standard of care.

Description:

The impacts from diabetes are both patient related and healthcare based. DFU is associated with a high mortality rate at 34% at 1 year. There is an associated higher limb amputation rate from DFU than other causes. The high mortality rate, high amputation rate and increased socio-economic burden means providing high quality evidence based DFU service provision should be a NHS priority. Offloading is recognised as the priority treatment for healing neuropathic and neuro-ischaemic plantar foot ulcers. Since the provision of non removable devices or total contact casts (TCC) is poor, options have to be available that are equivalent in effectiveness at off loading and healing DFU. By improving the quality of offloading choices and acceptability for devices this will improve healing rates and reduce the cost burden where currently in the UK diabetic foot care in 2015 accounted for 0.6%/585.5million pounds of the NHS budget. The evidence for effectiveness of non removable devices is poor. Therefore any device that offloads to the equivalent or more than previous devices and current usual standard of care must be evidenced. The new PulseFlow DF boot is such a device which claims to off load but has little or no evidence on DFU subjects. Thus the primary aim of this study is to observe forefoot plantar pressures in a cross sectional purposively selected sample compared to usual standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Plantar forefoot diabetic foot ulcer over the 1st, 2nd, 3rd, 4th or 5th MTP joints

2. Neuropathic or Neuro-Ischaemic classification foot ulcer (taken from the TEXAS classification system)

3. Orthotic intervention for offloading/usual standard

4. English speaking and reading

5. Palpable foot pulses and/or Ankle Brachial Pressure Indices of values 0.8 to 1.29.

Exclusion Criteria:

1. Being treated for or having an active Charcot Arthropathy

2. Ankle Brachial Pressure Indices of <0.8 and >1.29. Using a standardised reproducible instrument called the Huntleigh Dopplex Ability Unit (DA100PB).

3. Purely ischaemic classification foot ulcer

4. Clinically active Infection causing lower leg swelling

5. Current active osteomyelitis

6. Due to alterations in gait, patients with diagnosed vascular dementia, Parkinson's, alcoholism or other major medically related gait alterations i.e. intoxication, brain cancers, muscular degeneration diseases, inflammatory arthritis, etc. This does not include osteo-arthritis.

7. Fractures of the foot

8. Pregnancy

9. Patients with forefoot trans metatarsal or major amputations

10. Temporary, accommodating or footwear not designed to offload used as their USC

11. Under another trial regarding foot dressings or off loading -

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Device:
• PulseFlow DF boot
Offloading boot
• Usual standard of care
Usual standard of care (offloading device)
• Sham
Sham shoe (closest to barefoot or baseline pressures)

Locations

Country	Name	City	State
United Kingdom	The Leeds Teaching Hospitals NHS Trust.	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Time Integral	Gait analysis	1 day
Secondary	Modified Monitoring Orthopaedic Shoes questionnaire	Multiple choice questionnaire and visual analogue pain scale measuring relevant factors of use and usability of orthopaedic shoes from a patient's perspective.	1 day (post gait analaysis)