Diabetic Foot UlcerPhase 1NCT02328508
Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
A Phase 1 study testing Hyperbaric oxygen therapy in people with Diabetic Foot Ulcer and Diabetes, run by Chen-Yu Chen.
Trial summary
This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetes
- What is being tested?
- Hyperbaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 20 years of age
- a history of diabetes and a diagnosis of diabetic foot
- a wound classification of Grade 3 or below
- clear conscious and willing to participate in this study
- a signed consent form
Who cannot join
- less than 20 years of age, unwilling to participate
About this study
This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.
Read the detailed description
OBJECTIVE - This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.
RESEARCH DESIGN AND METHODS - This study was a randomized, single-center clinical trial. The effects of HBOT on patients in the experimental group were compared with the control group received only routine care. HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions). Data were collected at 4 segments: pre-treatment (before first administration of HBOT; T1), during treatment (at the tenth administration of HBOT; T2), post-treatment (at the twentieth administration of HBOT; T3), and treatment follow-up (two weeks after the last therapy ended; T4).
- Conditions
- Diabetic Foot Ulcer, Diabetes
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- hyperbaric oxygen therapy, diabetic foot ulcer, wound healing, inflammation, glycemic control, amputation, bacterial infection, quality of life
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Inflammation, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyDevice
Also called HBOT
HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions).
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric oxygen therapy | Experimental | The experimental group received treatments in a hyperbaric chamber for 120-min per session, once per day, and five days per week for four consecutive weeks (20 treatment sessions). Receives: Device: Hyperbaric oxygen therapy |
| Control | No intervention | The control group received only routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
The Wagner Ulcer Grade Classification System for wound physiological index
Measured: 4 weeks
Secondary outcomes (5)
inflammation index
Erythrocyte sedimentation rate, ESR; C-reactive protein, CRP
Measured: 4 weeks
amputation rate
Number of patients undergo surgical removal of a limb
Measured: 4 weeks
survival rate of tissue in the affected limb
blood flow perfusion scan
Measured: 4 weeks
bacteriological wound cultures
collect and culture bacteria from the wound to see whether a wound is infected, to identify the bacteria causing the infection
Measured: 4 weeks
glycemic control
Glycated Hemoglobin, HbA1c Hemoglobin, HbA1c
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chen-Yu Chen
- Sponsor type
- University, hospital or other
- Collaborators
- I-Shou University
- Responsible party
- Sponsor-investigator, Chen-Yu Chen, Chang Gung Memorial Hospital
- Investigators
- Chen-Yu Chen, Master, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328508
- Sponsor's protocol ID
- 100-0876B, 101-0507C
- Status last verified
- Dec 2014
- First submitted
- 25 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy in Diabetics With Chronic Foot Ulcers and Improvement of Quality of Life
- ClinicalTrials.gov ID
- NCT02328508
- Acronym / sponsor ID
- 100-0876B, 101-0507C
- Conditions
- Diabetic Foot Ulcer, Diabetes
- Keywords
- hyperbaric oxygen therapy, diabetic foot ulcer, wound healing, inflammation, glycemic control, amputation, bacterial infection, quality of life
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Chen-Yu ChenUniversity, hospital or other
- Collaborators
- I-Shou University
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.
Detailed description
OBJECTIVE - This study evaluated the effect of hyperbaric oxygen therapy (HBOT) on wound healing, inflammation index, glycemic control, amputation rate, survival rate of tissue, bacterial wound cultures, and quality of life (QOL) in diabetic foot ulcer (DFU) patients with diabetes.
RESEARCH DESIGN AND METHODS - This study was a randomized, single-center clinical trial. The effects of HBOT on patients in the experimental group were compared with the control group received only routine care. HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions). Data were collected at 4 segments: pre-treatment (before first administration of HBOT; T1), during treatment (at the tenth administration of HBOT; T2), post-treatment (at the twentieth administration of HBOT; T3), and treatment follow-up (two weeks after the last therapy ended; T4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen therapy | Experimental | Device: Hyperbaric oxygen therapyThe experimental group received treatments in a hyperbaric chamber for 120-min per session, once per day, and five days per week for four consecutive weeks (20 treatment sessions). |
| Control | No intervention | –The control group received only routine care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- over 20 years of age
- a history of diabetes and a diagnosis of diabetic foot
- a wound classification of Grade 3 or below
- clear conscious and willing to participate in this study
- a signed consent form
Key exclusion criteria (1 listed)
- less than 20 years of age, unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyAlso: HBOTHBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions). | Device | hyperbaric oxygen therapy |
Primary outcome
wound healing
Time frame: 4 weeks
The Wagner Ulcer Grade Classification System for wound physiological index
5 secondary outcomes
inflammation index
Time frame: 4 weeks
amputation rate
Time frame: 4 weeks
survival rate of tissue in the affected limb
Time frame: 4 weeks
bacteriological wound cultures
Time frame: 4 weeks
glycemic control
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
Related trials for Diabetic Foot Ulcer
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PAW-Hydrogel for Chronic Wound Healing
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen-Yu Chen, Master principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperbaric oxygen therapy in people with Diabetic Foot Ulcer and Diabetes, run by Chen-Yu Chen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.