Efficacy and safety of ointment containing 5% essential oil from Mammea suriga (Buch.- Ham. ex Roxb.) Kosterm. flower buds in treatment of diabetic foot ulcers: A multicentric parallel group randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 308
- 试验地点
- 3
- 主要终点
- Efficacy: Proportion of participants achieving complete healing
研究概览
简要总结
Patients seeking treatment at the Medicine/Surgery OPD at 3 selected hospitals, aged 18-70 years with clinically diagnosed diabetes (HbA1c > 6.5%) having diabetic foot ulcers as per University of Texas Grade 1 or 2 with stage A or B and size between 15 to 40 cm2 will be subjected to detailed screening. Consecutive patients fulfilling the inclusion/exclusion criteria will be enrolled for the study after obtaining written informed consent, and randomly assigned to one of two groups in a 1:1 ratio using computer-generated random sequences. The control group will receive standard dressing with sterile saline gauze pads with moisturizing agents topically, daily morning for 8 weeks or till complete healing. The intervention group will receive dressing with an ointment containing M. suriga EO (5%), daily morning for 8 weeks or till complete healing, whichever is earlier. For mild infected ulcers, betadine ointment will be used in addition with the dressing and oral antibiotics will be given based on the culture and sensitivity report in both the groups. Participants will be followed up weekly at week 1, 2, 4, 6 and 8. At all follow-up visits, ulcer size will be evaluated whereas complete healing will be evaluated at week 4, 6 and 8. HbA1c testing will be done at week 6 and 8. Quality of life assessment will be done using WHO-QoL-BREF at the baseline and end of the study.
Hypothesis - Application of M. suriga EO ointment results in complete healing of a larger proportion of diabetic foot ulcers as compared to standard dressing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients with age between 18 to 70 years
- •Clinically diagnosed diabetes (HbA1c greater than 6.5 %) and with diabetic foot ulcers as per University of Texas Grade 1 or 2 with stage A or B and size between 15 to 40 cm2
- •Uninfected Diabetic foot ulcers or Diabetic foot ulcers with mild infection as per International Working Group on the Diabetic Foot (IWGDF) and Infectious Disease Society of America (IDSA) (Matilde Monteiro-Soares et al.
- •Diabetic foot ulcers less than 2 weeks old at the time of screening
- •Willing to give consent for participating in the study.
排除标准
- •Patients with necrosis, purulence, or sinus tracts in the target ulcer not removable by debridement
- •Compromised blood flow as indicated by USG colour Doppler report for the affected limbs anterior tibial, posterior tibial, and dorsalis pedis arteries which the treating physician feels may affect the ulcer healing
- •Patients undergone prior amputation due to diabetic wounds
- •HbA1c greater than 12%
- •Patients on regular medicines which may affect wound healing (corticosteroids, immunosuppressive drugs, cancer chemotherapy, NSAIDs, anticoagulants and anticonvulsant drugs)
- •Pregnant and lactating women
- •Any condition which in the opinion of the investigator will place the subject at risk or will influence the conduct of the study or interpretation of results.
结局指标
主要结局
Efficacy: Proportion of participants achieving complete healing
时间窗: 4 week | 6 week | 8 week
次要结局
- Change in ulcer size (surface area)(Baseline)
- Quality of life using WHO QoL-BREF questionnaire(Baseline)
- Safety: Adverse events for Safety outcomes at any follow-up, infection rate of ulcer(1 week)
研究者
Dr Harsha Hegde
ICMR National Institute of Traditional Medicine Belagavi