Short Duration Hyperbaric Oxygen Therapy to Improve HbA1c, Leukocyte, and Serum Creatinine
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| ClinicalTrials.gov Identifier: NCT03615755 |
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Recruitment Status :
Completed
First Posted : August 6, 2018
Last Update Posted : May 4, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperbaric Oxygen Therapy Diabetic Foot Ulcer Type II Diabetes Mellitus | Other: Hyperbaric Oxygen Therapy (HBOT) | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| 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 |
| Actual Study Start Date : | December 27, 2016 |
| Actual Primary Completion Date : | March 31, 2017 |
| Actual Study Completion Date : | March 31, 2017 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Standard Therapy
Standard Therapy (controlling blood sugar, antibiotic drug, ulcer debridement, wound care, offloading)
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Active Comparator: Combination Therapy
Standard Therapy with adjuvant Hyperbaric Oxygen Therapy (Total 10 sessions, each session used pressure 2.4 ATA for 90 minutes per day)
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Other: 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. |
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- patients who had severe organs dysfunction such as heart failure, pulmonary infection, pneumothorax, chronic obstructive pulmonary disease, and stroke.
Documents provided by Hendry Irawan, Udayana University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hendry Irawan, Clinical Research, Udayana University |
| ClinicalTrials.gov Identifier: | NCT03615755 |
| Other Study ID Numbers: |
HBOT_DFU |
| First Posted: | August 6, 2018 Key Record Dates |
| Last Update Posted: | May 4, 2020 |
| Last Verified: | May 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hyperbaric Oxygen Therapy Diabetic Foot Ulcer HbA1c Leukocyte Serum creatinine |
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Diabetic Foot Foot Ulcer Diabetes Mellitus, Type 2 Ulcer Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer |
Skin Ulcer Skin Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Foot Diseases Glucose Metabolism Disorders Metabolic Diseases |