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Completed

NCT Number: NCT00953186

Hyperbaric Oxygen Therapy as Adjunctive Treatment of Chronic Diabetic Foot Ulcers

The purpose of this study is to evaluate if hyperbaric oxygen therapy heels more foot ulcers as compared to placebo in patients with diabetes mellitus and chronic foot ulcers.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Foot Diseases Foot Ulcer Glucose Metabolism Disorders Healing Ischemia Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dept Anesthesiology, Helsingborg Hospital

Helsingborg, S 221 57, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diabetes mellitus,
  • foot ulcer with duration > 3 months,
  • treatment at Diabetes foot clinic for > 2 months,
  • vascular surgical intervention had not been recommended for the affected lower limb.

Exclusion criteria

  • severe obstructive pulmonary disease,
  • malignancy and untreated thyrotoxicosis),
  • current drug or alcohol misuse,
  • vascular surgery in the lower limbs within the last two months,
  • participation in another study or suspected poor compliance.

Treatment and study plan

hyperbaric air

Device

air at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber

HBOT

Device

100 % oxygen at 2,5 atmospheres for 90 minutes/day, 5 days a week for 8 weeks treatment given in hyperbaric chamber

Primary outcomes

  1. Ulcer healing

    Time frame: 3, 6, 9, 12, 18, 24 months

Secondary outcomes

  1. Amputationrate

    Time frame: 6, 12, 24 months

  2. time to ulcer healing

    Time frame: 24 months

  3. QoL

    Time frame: 3, 6, 12, 18, 24 months

Sponsors and collaborators

Lead sponsor

Mrs. Thelma Zoegas Foundation

Other

Collaborators

  • Gorthons Foundation Helsingborg Sweden
  • Lund University
  • Region Skåne Sweden

Registry information

Official study title

Hyperbaric Oxygen Therapy as Adjunctive Treatment in Diabetics With Chronic Foot Ulcers

Acronym: HODFU

Important dates

Study start
2002
Primary completion
2009
Study completion
2009
First posted
Aug 6, 2009
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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