Indications

PulseFlowDF is indicated for the treatment of active diabetic foot ulcer at the following sites:

  • Plantar aspect of the 1st metatarsophalangeal joint (MTPJ)
  • 2nd - 5th MTPJ
  • Heel
  • Plantar and dorsum aspects of the toes
  • Dorsum of the foot

Contraindications

PulseFlow is contraindicated in patients with:

  • Acute Charcot foot
  • Uncontrolled, active infection
  • Deep collections tracked sepsis requiring drainage
  • Acute foot fracture or rigid foot deformities

Patient Evaluation

After clinical assessment of patient suitability ensure the feet can be accommodated in the device by testing with the toe box guide, and determine the shoe size required using the PulseFlowDF sizing guide

PulseFlowDF may be supplied with the shin unit, offloader and IPC mechanism fitted to either the right or left side, depending on ulcer location. This should be specified at the time of ordering.

Treatment Regimen

The PulseFlowDF device should be worn throughout the patient’s waking hours for up to 1000 hours (approximately 12 weeks). The device should be removed and recharged overnight. Treatment data may be downloaded for analysis using the cable provided.

Will Patients Comply With PulseFlowDF Treatment?

Studies show that patients wear prescribed footwear or offloading devices for only a limited percentage of their total ambulatory time or steps made [16], [3], [28], [19] and these patients present with significantly worse clinical outcomes. [7], [22], [18]

Reasons for non-compliance include the device interfering with the activities of daily living, embarrassment at wearing the device and a lack of understanding of the clinical benefits of treatment. While non-removable devices such as total contact casts can overcome some of these issues, they also have disadvantages including being contraindicated in infected or significantly oedematous tissues, and posing a risk of collision injury to the contralateral leg.

PulseFlowDF is carefully designed to be worn under clothing and to look like normal footwear to reduce any patient self-consciousness arising from treatment.

The integral treatment monitoring software further motivates patient compliance by providing robust feedback at follow-up visits on the frequency and duration of use, while the built-in bioimpedence sensor prevents the device being used without a leg present.

What happens after treatment with PulseFlowDF?

Once treatment is completed, the PulseFlow mechanism may be removed, leaving the patient with high quality footwear that continue to promote a healthy in-shoe environment and protect against future tissue breakdown.

“Being able to review wear time using the software was invaluable [as] there was a suspicion patients were not wearing the offloading devices. It was possible to show participants how little they had used the device and to reiterate the need to use it. This was successful in all participants except one”

Mr Richard Leigh

Head of Podiatry, Royal Free London Hospitals NHS Foundation Trust