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Clinical Trials/ISRCTN17892066
ISRCTN17892066Terminated未知

A feasibility study to assess the effect of the PulseFlowDF in the treatment of diabetic foot ulcers

Salford Royal NHS Foundation Trust0 sites40 target enrollmentStarted: December 15, 2016Last updated:
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Conditions

Trial Snapshot

Phase
未知
Status
Terminated
Sponsor
Enrollment
40
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. >17 years of age
  • •2. Consultant or GP diagnosis of diabetes mellitus (type I or II) documented on the electronic patient record with HbA1C greater than 48mmol/mol recorded in the last 6 months
  • •3. Controlled diabetes as defined as an HbA1c of 86mm/mol (11%) in the last 3 months
  • •4. Foot ulcers (defined by the University Texas wound Classification grades 1A, 1B, 1C, 2A, 2B, 2C) and greater than the volume of 30mm3 (as determined by 3D camera) and or minimum length and width of 5mm x 5mm and 2mm depth
  • •5. Foot ulcer (as defined above) with or without mild infection as defined by IDSA as local infection involving only the skin and the subcutaneous tissue (without involvement of deeper tissues and without systemic signs as described below). If erythema, must be >0.5 cm to = 2cm around the ulcer, once all other causes of an inflammatory response of the skin (e.g. trauma, gout, acute Charcot neuro-osteoarthropathy, fracture, thrombosis and venous stasis) are excluded (Lipsky et al. 2012)
  • •6. People with mild peripheral arterial disease defined as the absence of palpable pulses and or monophasic Doppler signals using audio ultrasound evaluation with an ABPI of 0.8 to 0.51 (or if vessels not compressible e.g. ABPI >1.1) an absolute toe pressure of >51mmHg
  • •7. Foot ulcer at any of the following sites:
  • •7.1. First metatarsophalangeal joint (MTPJ) plantar aspect
  • •7.2. 2nd-5th MTPJs
  • •7.3. Heel
  • •7.4. Plantar aspect of toe/s
  • •8. Patients who have undergone lower extremity surgery / amputation may be enrolled into the study subject to the clinical judgement of the investigator
  • •9. Willingness to adhere to standard clinical care for diabetic foot ulcer as per NICE guidelines (CG10, CG 119 NG19) including dressing regime, pressure reduction and clinical review evidenced by medical history
  • •10. Competence to provide informed consent
  • •11. Foot size ranging from 5-13 (UK)

Exclusion Criteria

  • •1. Ulcer on plantar surface of medial longitudinal arch of foot
  • •2. Severe peripheral arterial disease as evidenced by an ABPI of <0.5 (or if vessels not compressible e.g. ABPI >1.1) an absolute toe pressure of <50mmHg
  • •3. Evidence of venous stasis ulcers or ulcers secondary to tropical disease
  • •4. Moderate to severe infection defined by IDSA as local infection (as described above) with erythema >2cm, or involving structures deeper than skin and subcutaneous tissues (e.g. abscess, osteomyelitis, septic arthritis, fasciitis) and no systemic inflammatory response signs: Local infection (as described above) with the signs of SIRS, as manifested by =2 of the following (Lipsky et al. 2012):
  • •4.1. Body temperature >38°C or <36°C
  • •4.2. Heart rate >90 beats/min
  • •4.3. Respiratory rate >20 breaths/min or PaCO2 <32 mmHg
  • •4.4. White blood cell count >12 000 or <4000 cells/µ Lor = 10% immature (band) form
  • •5. Mild infection of a foot ulcer (as defined above) and on <4 weeks antibiotic treatment
  • •6. Acute septic arthritis
  • •7. Acute fractures of the foot including pathological, related to osteomyelitis
  • •8. Active Charcot Neuroarthropathy
  • •9. Cannot tolerate / unwilling to adhere to standard clinical care as evidenced by NICE guidelines, such as pressure reduction (CG10, CG 119)
  • •10. Current treatment with advanced wound therapies (NICE CG 119 1.1.36):
  • •10.1. Grafts
  • •10.2. Pinch grafts
  • •10.3. Dermal substitutes
  • •10.4. Biological wound therapies to stimulate epithelialisation including but not limited to: growth factors, stem cells, skin cell application and Lave
  • •10.5. Oxygen-delivering therapies
  • •10.6. Electro-stimulation devices
  • •10.7. Micro-current devices
  • •10.8. Laser, kinetic devices
  • •10.9. Negative pressure wound therapy
  • •10.10. Hydro-surgical debridement
  • •10.11. Extensive wound debridement as undertaken by orthopaedic and vascular surgeons requiring operative theatre
  • •11. Rigid foot deformity: Restriction of movement at the subtalar joint and/or the midtarsal joint
  • •12. Surgery for lower limb revascularisation in the 3 months
  • •13. People with functioning infrainguinal bypass grafts in situ and that in the opinion of the vascular consultant should not be placed in an orthotic boot
  • •14. Acute heart failure
  • •15. Pregnancy
  • •16. Participation in an interventional study within the last 30 days
  • •17. A history of any clinically significant disease or major disorder that in the opinion of the research officer and or Chief Investigator would not be conducive to study participation

Investigators

Sponsor
Salford Royal NHS Foundation Trust

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