Effect of Topical Ozone on The Healing Diabetic Foot Ulcer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05977309 |
Recruitment Status :
Not yet recruiting
First Posted : August 4, 2023
Last Update Posted : August 4, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Wound Heal Diabetic Foot Ulcer Ozone | Device: Topical ozone therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 430 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | In five wound care clinics on Java Island, Indonesia, 430 men and women with diabetic foot ulcer lesions participated in this randomised, triple-blind clinical trial. Inclusion criteria included women and men receiving treatment for diabetic foot ulcers, the Wagner scale, current blood sugar between 120 and 180 mg/dl, Hb1ac between 4.5 and 7%, lesion length greater than 5 cm, and infection. Exclusion criteria in this investigation, such as immunodeficiency disorders, are listed as examples. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Participants were randomly assigned to ozone therapy and placebo groups in a ratio of 1:1 using block randomization with Random Allocation Software (RAS) and block sizes of 4 and 6. By the number of samples, envelopes were prepared, and capsules were deposited within them. 1 to 430 were assigned to each envelope. The envelopes were opened in the order that the participants entered the study, and the type of intervention was determined. A person uninvolved in the sampling process prepared envelopes in the allocation order. In this study, researchers, subjects, and outcome evaluators were all blinded. |
Primary Purpose: | Treatment |
Official Title: | The Effect of Therapy Ozone Topical on The Healing Diabetic Foot Ulcer: A Triple-Blind Randomized Clinical Trial |
Estimated Study Start Date : | August 1, 2023 |
Estimated Primary Completion Date : | August 15, 2023 |
Estimated Study Completion Date : | August 30, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Effect of Topical Ozone on The Healing Diabetic Foot Ulcer
The topical ozone therapy group received standard wound care with modern dressings every three days for thirty days.
|
Device: Topical ozone therapy
the topical ozone therapy group received a concentration of 30 mg/L at a frequency of 30 minutes per day for 30 days. Participants received ozone therapy topically every three days for eight treatments.
Other Name: ozone therapy |
Placebo Comparator: Effect of Standart Wound Care on The Healing Diabetic Foot Ulcer
The placebo group received standard wound care with modern dressings thrice weekly for thirty days.
|
Device: Topical ozone therapy
the topical ozone therapy group received a concentration of 30 mg/L at a frequency of 30 minutes per day for 30 days. Participants received ozone therapy topically every three days for eight treatments.
Other Name: ozone therapy |
- Comparison of the effects of topical ozone therapy and placebo on the healing of diabetic foot ulcers. [ Time Frame: Analysis was performed at the Baseline, fifteen days after treatment began, and thirty days after treatment began. ]Comparing the healing of diabetic foot ulcers in the topical ozone therapy group with the control group. The dimensions of a wound can be assessed for wound-healing purposes by employing a photographic apparatus to quantify the length and width of the wound.
- Comparison of ischemia to variations in skin oxygen levels by transcutaneous oxygenation (TcPO2) assessment of topical ozone therapy and placebo in diabetic foot ulcers [ Time Frame: Analysis was performed at the Baseline, fifteen days after treatment began, and thirty days after treatment began. ]Differences in epidermal oxygenation levels between diabetic foot ulcers treated with topical ozone therapy and those treated with ozone. The utilization of a scale questionnaire (WIFI) for measurement. The measurement of oxygen levels in the skin to assess ischemia can be conducted using transcutaneous oxygen (TcPO2) measurements, employing the PeriFlux 6000 instrument, which provides a measurement scale. In the context of blood pressure, the categorizations are as follows: normal blood pressure is defined as being greater than 45 mmHG, mild blood pressure falls within the range of 40-45 mmHg, moderate blood pressure ranges from 20-39 mmHg, severe blood pressure is within the range of 1-20 mmHg, and critical blood pressure is defined as being at 0 mmHg.
- Comparison of improvement in peripheral microcirculation from ischemia in diabetic foot ulcers between topical ozone therapy and a control group using the toe ankle-brachial index (TBI) measurement. [ Time Frame: Analysis was performed at the Baseline, fifteen days after treatment began, and thirty days after treatment began. ]Comparing the improvement in peripheral microcirculation of the foot in diabetic foot ulcers treated with topical ozone versus those treated with ozone. The utilization of a scale questionnaire (WIFI) for measurement. Limb ischemia can be assessed by examining the toe brachial index (TBI) using the Vascular Doppler instrument. The TBI is measured on a scale where a value greater than 0.7 mmHg is considered normal, a value between 0.4 and 0.7 mmHg is considered abnormal, and a value below 0.4 mmHg is considered severe. This examination allows for the evaluation of peripheral microcirculation and can help determine the extent of improvement in cases of limb ischemia.
- Comparison of topical ozone therapy and placebo groups for diabetic foot ulcer infection [ Time Frame: Analysis was performed at the Baseline, fifteen days after treatment began, and thirty days after treatment began ]Comparing the reduction of infection on the surface of diabetic foot ulcers in the groups receiving topical ozone therapy versus those receiving placebo. The utilization of a scale questionnaire (WIFI) for measurement purposes. The reduction in infection was assessed using an ordinal scale that categorized the severity of infection as follows: no infection (0), mild cellulitis measuring 2cm, moderate cellulitis exceeding 2cm, and severe sepsis/systemic infection.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion standarts:
- Patients with diabetic foot ulcers, both male and female, include both sexes.
- Size wound 4-80cm
- Value toe brachial index between 4-7 mmHg
- Value transcutaneous oxygen (TcPO2) levels range 1-45 mmHg
- Infection, area of cellulitis 1-2cm
Exclusion standarts:
- Immunodeficiency conditions
- Concurent ilness
- Size wound >80cm
- Value toe brachial index (TBI) <4 mmHg
- Value crititcal for transcutaneous oxygen (TcPO2) is 0 mmHg
- Systemic infection and sepsis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05977309
Contact: Asmat Burhan, MSN | +6285746157782 | asmatburhan@uhb.ac.id | |
Contact: Septian Mixrova Sebayang, MSN | +628529721449 | septiansebayang@uhb.ac.id |
Study Chair: | Asmat Burhan, MSN | Universitas of Harapan Bangsa |
Responsible Party: | Asmat Burhan, Chief Researcher in Nursing, Faculty of Health Sciences, Universitas Harapan Bangsa, Universitas Harapan Bangsa |
ClinicalTrials.gov Identifier: | NCT05977309 |
Other Study ID Numbers: |
UHarapanBangsa |
First Posted: | August 4, 2023 Key Record Dates |
Last Update Posted: | August 4, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Only participant data is utilised in this study. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
ozone wound healing diabetic foot ulcer |
Diabetic Foot Foot Ulcer 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 |