Effectiveness and acceptableness of a portable device to deliver oxygen directly to long-standing foot ulcers

Not Applicable

Completed

• Conditions: Foot ulcer; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN17337965
• Lead Sponsor: Cumbria Partnership NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-11
• Study Completion: 2022-10-31
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Clinical diagnosis of a Foot Ulcer, present on area that is measurable with a grid sheet (this can include plantar, calcaneus, dorsal, hallux, apex, or ankle based ulcers). This includes DFU, peripheral arterial disease related wound, or other aetiology
2. No minimum chronicity applicable for the index foot ulcer
3. Adult patients aged > = 18 years
4. Patients with recurrent wounds, including multiple wounds, are eligible. The largest of the wounds, that is measurable with a grid sheet, will be selected for the trial
5. Mental capacity to give consent

Exclusion Criteria

Current participant exclusion criteria as of 03/03/2022:
1. Limited life expectancy, i.e. undergoing palliative care
2. Active infection in foot ulcer that cannot be managed in podiatry service (ie requires specialist secondary care intervention)
3. Ulcer penetrating the tendon, periosteum, or bone.
4. Foot ulcer in area of the foot, e.g. in between toes, which would make exact ulcer size measurement, or application of the Natrox device, impossible.
5. Pregnant, actively planning to become pregnant, or lactating (all self-reported)
6. Currently receiving intravenous antibiotics, or within one week of receiving iv antibiotics (topical and oral antibiotics are not an exclusion criterion).
7. Participating in another research study involving an investigational product that is related to the DFU or a co-morbidity that may influence wound healing (incl diabetes, peripheral arterial disease, or immune disorders).
8. Use of barrier cream/ointment and honey-based dressings (as per Natrox device instructions)
9. Concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives, or significantly impede compliance with NATROX® therapy.

Previous participant exclusion criteria:
1. Limited life expectancy, i.e. undergoing palliative care
2. Active infection in foot ulcer that cannot be managed in podiatry service (ie requires specialist secondary care intervention)
3. Ulcer penetrating the tendon, periosteum or bone.
4. Foot ulcer in area of the foot, e.g. in between toes, which would make exact ulcer size measurement, or application of the Natrox device, impossible.
5. Pregnant, actively planning to become pregnant, or lactating (all self-reported)
6. Currently receiving intravenous antibiotics, or within one week of receiving iv antibiotics (topical and oral antibiotics are not an exclusion criterion).
7. Participating in another research study involving an investigational product that is related to the DFU or a co-morbidity that may influence wound healing (incl diabetes, peripheral arterial disease, or immune disorders).
8. Concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives, or significantly impede compliance with NATROX® therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified