Hyperbaric Oxygen TherapyNCT03615755
Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine
A study testing Hyperbaric Oxygen Therapy (HBOT) in people with Hyperbaric Oxygen Therapy and Diabetic Foot Ulcer, run by Hendry Irawan.
Trial summary
The investigators want to evaluate the short duration HBOT can improve glycohemoglobin (HbA1c) levels, leukocyte count, and serum creatinine levels in patients with DFU (diabetic foot ulcer) Wagner 3-4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperbaric Oxygen Therapy, Diabetic Foot Ulcer, Type II Diabetes Mellitus
- What is being tested?
- Hyperbaric Oxygen Therapy (HBOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 27 Dec 2016to 31 Mar 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who had type 2 diabetes and DFU Wagner class 3 or 4, aged over 18 years, and underwent debridement with or without toe amputation.
Who cannot join
- patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke.
About this study
Official title: A Pilot Study of Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine in Patient With Diabetic Foot Ulcer Wagner 3-4
The investigators want to evaluate the short duration HBOT can improve glycohemoglobin (HbA1c) levels, leukocyte count, and serum creatinine levels in patients with DFU (diabetic foot ulcer) Wagner 3-4.
Read the detailed description
This study uses pretest and posttest control group design. All DM (diabetes mellitus) patients with DFU at Sanglah General Hospital, Denpasar who meet the inclusion and exclusion criteria and willing to follow the research procedure. All patients are signing the agreement paper after getting research explanation. All patients were briefed on the study research using HBOT. If the patients are willing to participate in the study and use HBOT was grouped to combination therapy, if the patients are willing to participate in the study but do not want to use HBOT was grouped to standard therapy, but if the patients are not willing participate then excluded.
All patients were taken blood test for HbA1c levels, leukocyte count, and serum creatinine levels before debridement, then grouped for standard therapy or standard therapy with 10 sessions of HBOT. One session of HBOT uses oxygen at 2.4 ATA (atmosphere absolute) for 90 minutes per day at multiplace hyperbaric chamber. This therapy is given five sessions in a week, so it takes two weeks. At the end of therapy, all blood tests were performed again in both groups.
The inclusion criteria were patients who had type 2 diabetes and DFU Wagner class 3 or 4, aged over 18 years, and underwent debridement with or without toe amputation. The exclusion criteria were patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke.
Statistical analysis using SPSS 17.0 (SPSS Inc., Chicago, Illinois, USA). All variables were described before and after treatment. Analysis pretest and posttest values on both groups were used paired T-test and independent T-test. The statistical test results are significant if p < 0.05.
- Being tested
- Hyperbaric Oxygen Therapy (HBOT)
- Keywords
- Hyperbaric Oxygen Therapy, Diabetic Foot Ulcer, HbA1c, Leukocyte, Serum creatinine
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen Therapy (HBOT)Other
The investigators used 10 sessions of HBOT. One session of HBOT uses oxygen at 2.4 ATA for 90 minutes per day at multiplace hyperbaric chamber. This therapy is given five sessions in a week, so it takes two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | No intervention | Standard Therapy (controlling blood sugar, antibiotic drug, ulcer debridement, wound care, offloading) |
| Combination Therapy | Active comparator | Standard Therapy with adjuvant Hyperbaric Oxygen Therapy (Total 10 sessions, each session used pressure 2.4 ATA for 90 minutes per day) Receives: Other: Hyperbaric Oxygen Therapy (HBOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c levels
HbA1c levels test before the patients were done debridement (baseline) and after 2 weeks therapy.
Measured: 2 weeks
Leukocyte count
Leukocyte count test before the patients were done debridement (baseline) and after 2 weeks therapy.
Measured: 2 weeks
Serum creatinine
Serum creatinine levels test before the patients were done debridement (baseline) and after 2 weeks therapy.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start27 Dec 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Hyperbaric Oxygen TherapyStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hendry Irawan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hendry Irawan, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615755
- Sponsor's protocol ID
- HBOT_DFU
- Status last verified
- May 2020
- First submitted
- 9 Jul 2018
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kementerian Kesehatan Republik Indonesia. Diabetes Melitus Penyebab Kematian Nomor 6 di Dunia: Kemenkes Tawarkan Solusi Cerdik Melalui Posbind. (online) 2013 Sep. [cited 2016 Aug. 30] Available from: http://www.depkes.go.id/article/print/2383/diabetes-melitus-penyebab-kematian-nomor-6-di-dunia-kemenkes-tawarkan-solusi-cerdik-melalui-posbindu.html.
World Health Organization. Global status report on noncommunicable diseases 2010. Switzerland: WHO Press; 2011.
Societe de Pathologie Infectieuse de Langue Francaise. Management of diabetic foot infections. Short text. Societe de Pathologie Infectieuse de Langue Francaise. Med Mal Infect. 2007 Jan;37(1):1-25. doi: 10.1016/j.medmal.2006.09.002. No abstract available. English, French.
PubMed 17357221World Health Organization. Global Report on Diabetes. Switzerland: WHO Press; 2016.
Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66. doi: 10.1016/S1067-2516(07)60001-5.
PubMed 17280936Wounds International. International Best Practice Guidelines: Wound Management in Diabetic Foot Ulcers. London: Wounds International A division of Schofield Healthcare Media Limited Enterprise House; 2013.
Kessler L, Bilbault P, Ortega F, Grasso C, Passemard R, Stephan D, Pinget M, Schneider F. Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers: a prospective randomized study. Diabetes Care. 2003 Aug;26(8):2378-82. doi: 10.2337/diacare.26.8.2378.
PubMed 12882865Waniczek D, Kozowicz A, Muc-Wierzgon M, Kokot T, Swietochowska E, Nowakowska-Zajdel E. Adjunct methods of the standard diabetic foot ulceration therapy. Evid Based Complement Alternat Med. 2013;2013:243568. doi: 10.1155/2013/243568. Epub 2013 Jun 13.
PubMed 23843866Jeffcoate WJ, Game FL. Evidence for the use of biological therapies in ulcers of the foot in diabetes. BioDrugs. 2014 Feb;28(1):1-6. doi: 10.1007/s40259-013-0052-3.
PubMed 23832595Flood MS. Hyperbaric Oxygen Therapy for diabetic Foot Ulcers. The Journal of Lancaster General Hospital. 2007;2:140-145.
Bhutani S, Vishwanath G. Hyperbaric oxygen and wound healing. Indian J Plast Surg. 2012 May;45(2):316-24. doi: 10.4103/0970-0358.101309.
PubMed 23162231Karadurmus N, Sahin M, Tasci C, Naharci I, Ozturk C, Ilbasmis S, Dulkadir Z, Sen A, Saglam K. Potential benefits of hyperbaric oxygen therapy on atherosclerosis and glycaemic control in patients with diabetic foot. Endokrynol Pol. 2010 May-Jun;61(3):275-9.
PubMed 20602302Aydin F, Kaya A, Karapinar L, Kumbaraci M, Imerci A, Karapinar H, Karakuzu C, Incesu M. IGF-1 Increases with Hyperbaric Oxygen Therapy and Promotes Wound Healing in Diabetic Foot Ulcers. J Diabetes Res. 2013;2013:567834. doi: 10.1155/2013/567834. Epub 2013 Feb 26.
PubMed 23671876El-Kader SMA, Ashmawy EM. Impact of Different Therapeutic Modalities on Healing of Diabetic Foot Ulcers. Eur J Gen Med. 2015;12:319-325.
Gupta SK, Sharma AK. Effects of hyperbaric oxygen therapy on haematological and biochemical parameters. Ind J Aerospace Med. 2000;44:1-5.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine in Patient With Diabetic Foot Ulcer Wagner 3-4
- ClinicalTrials.gov ID
- NCT03615755
- Acronym / sponsor ID
- HBOT_DFU
- Keywords
- Hyperbaric Oxygen Therapy, Diabetic Foot Ulcer, HbA1c, Leukocyte, Serum creatinine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hendry IrawanUniversity, hospital or other
- Study start
- 27 Dec 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 6 Aug 2018 (actual)
- 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.
The investigators want to evaluate the short duration HBOT can improve glycohemoglobin (HbA1c) levels, leukocyte count, and serum creatinine levels in patients with DFU (diabetic foot ulcer) Wagner 3-4.
Detailed description
This study uses pretest and posttest control group design. All DM (diabetes mellitus) patients with DFU at Sanglah General Hospital, Denpasar who meet the inclusion and exclusion criteria and willing to follow the research procedure. All patients are signing the agreement paper after getting research explanation. All patients were briefed on the study research using HBOT. If the patients are willing to participate in the study and use HBOT was grouped to combination therapy, if the patients are willing to participate in the study but do not want to use HBOT was grouped to standard therapy, but if the patients are not willing participate then excluded.
All patients were taken blood test for HbA1c levels, leukocyte count, and serum creatinine levels before debridement, then grouped for standard therapy or standard therapy with 10 sessions of HBOT. One session of HBOT uses oxygen at 2.4 ATA (atmosphere absolute) for 90 minutes per day at multiplace hyperbaric chamber. This therapy is given five sessions in a week, so it takes two weeks. At the end of therapy, all blood tests were performed again in both groups.
The inclusion criteria were patients who had type 2 diabetes and DFU Wagner class 3 or 4, aged over 18 years, and underwent debridement with or without toe amputation. The exclusion criteria were patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke.
Statistical analysis using SPSS 17.0 (SPSS Inc., Chicago, Illinois, USA). All variables were described before and after treatment. Analysis pretest and posttest values on both groups were used paired T-test and independent T-test. The statistical test results are significant if p < 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | No intervention | –Standard Therapy (controlling blood sugar, antibiotic drug, ulcer debridement, wound care, offloading) |
| Combination Therapy | Active comparator | Other: Hyperbaric Oxygen Therapy (HBOT)Standard Therapy with adjuvant Hyperbaric Oxygen Therapy (Total 10 sessions, each session used pressure 2.4 ATA for 90 minutes per day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who had type 2 diabetes and DFU Wagner class 3 or 4, aged over 18 years, and underwent debridement with or without toe amputation.
Key exclusion criteria (1 listed)
- patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke.
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 Therapy (HBOT)The investigators used 10 sessions of HBOT. One session of HBOT uses oxygen at 2.4 ATA for 90 minutes per day at multiplace hyperbaric chamber. This therapy is given five sessions in a week, so it takes two weeks. | Other | Combination Therapy |
Primary outcome
HbA1c levels
Time frame: 2 weeks
HbA1c levels test before the patients were done debridement (baseline) and after 2 weeks therapy.
Leukocyte count
Time frame: 2 weeks
Leukocyte count test before the patients were done debridement (baseline) and after 2 weeks therapy.
Serum creatinine
Time frame: 2 weeks
Serum creatinine levels test before the patients were done debridement (baseline) and after 2 weeks therapy.
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 4 May 2020.
- BackgroundKementerian Kesehatan Republik Indonesia. Diabetes Melitus Penyebab Kematian Nomor 6 di Dunia: Kemenkes Tawarkan Solusi Cerdik Melalui Posbind. (online) 2013 Sep. [cited 2016 Aug. 30] Available from: http://www.depkes.go.id/article/print/2383/diabetes-melitus-penyebab-kematian-nomor-6-di-dunia-kemenkes-tawarkan-solusi-cerdik-melalui-posbindu.html.
- BackgroundWorld Health Organization. Global status report on noncommunicable diseases 2010. Switzerland: WHO Press; 2011.
- Background: PubMed 17357221Societe de Pathologie Infectieuse de Langue Francaise. Management of diabetic foot infections. Short text. Societe de Pathologie Infectieuse de Langue Francaise. Med Mal Infect. 2007 Jan;37(1):1-25. doi: 10.1016/j.medmal.2006.09.002. No abstract available. English, French.
- BackgroundWorld Health Organization. Global Report on Diabetes. Switzerland: WHO Press; 2016.
- Background: PubMed 17280936Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66. doi: 10.1016/S1067-2516(07)60001-5.
- BackgroundWounds International. International Best Practice Guidelines: Wound Management in Diabetic Foot Ulcers. London: Wounds International A division of Schofield Healthcare Media Limited Enterprise House; 2013.
- Background: PubMed 12882865Kessler L, Bilbault P, Ortega F, Grasso C, Passemard R, Stephan D, Pinget M, Schneider F. Hyperbaric oxygenation accelerates the healing rate of nonischemic chronic diabetic foot ulcers: a prospective randomized study. Diabetes Care. 2003 Aug;26(8):2378-82. doi: 10.2337/diacare.26.8.2378.
- Background: PubMed 23843866Waniczek D, Kozowicz A, Muc-Wierzgon M, Kokot T, Swietochowska E, Nowakowska-Zajdel E. Adjunct methods of the standard diabetic foot ulceration therapy. Evid Based Complement Alternat Med. 2013;2013:243568. doi: 10.1155/2013/243568. Epub 2013 Jun 13.
- Background: PubMed 23832595Jeffcoate WJ, Game FL. Evidence for the use of biological therapies in ulcers of the foot in diabetes. BioDrugs. 2014 Feb;28(1):1-6. doi: 10.1007/s40259-013-0052-3.
- BackgroundFlood MS. Hyperbaric Oxygen Therapy for diabetic Foot Ulcers. The Journal of Lancaster General Hospital. 2007;2:140-145.
- Background: PubMed 23162231Bhutani S, Vishwanath G. Hyperbaric oxygen and wound healing. Indian J Plast Surg. 2012 May;45(2):316-24. doi: 10.4103/0970-0358.101309.
- Background: PubMed 20602302Karadurmus N, Sahin M, Tasci C, Naharci I, Ozturk C, Ilbasmis S, Dulkadir Z, Sen A, Saglam K. Potential benefits of hyperbaric oxygen therapy on atherosclerosis and glycaemic control in patients with diabetic foot. Endokrynol Pol. 2010 May-Jun;61(3):275-9.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy (HBOT) in people with Hyperbaric Oxygen Therapy and Diabetic Foot Ulcer, run by Hendry Irawan.
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 1 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 4 May 2020. 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.
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?
HbA1c levels (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615755, which also lists 33 linked publications.
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 4 May 2020.