AN OPEN LABEL CONTROLLED RANDOMISED CLINICAL STUDY TO EVALUATE EFFECT OF SURGICAL DEBRIDEMENT AND MAGGOT DEBRIDEMENT IN KAPHAJA DUSTA VRANA VIS-À-VIS DIABETIC FOOT ULCER
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Attaining healthy granulation tissue and conversion of non healing ulcer to healing ulcer
研究概览
简要总结
Sushrutha Samhita being a pioneer classical reference in Ayurveda where Acharya Sushrutha described Maggots in debridement in the concept of Kaphaja arbuda management and certain drugs and materials as culture media to be utilized in cultivation of maggots
Un-affordability fear of losing limb profuse blood loss lack of awareness and false ideology regarding anaesthesia to the people are becoming the gateway towards nonsurgical care and treatment of Diabetic Foot Ulcer
Hence it is an attempt on the subjects who are diagnosed with Diabetic Foot Ulcer under the title of Kaphaja Dushtavrana based on its Lakshanasare taken for study and comparing Maggot debridement and Surgical debridement to evaluate the effect and bring rays on nonsurgical Maggot debridement
SAMPLE SIZE:
40 subjects suffering from Diabetic Foot Ulcer
· Group A :20 Subjects will be treated with Maggot debridement.
· Group B :20 Subjects will be treated with Surgical debridement.
PRE - OPERATIVE PROCEDURE
GROUP A:
· Informed consent will be taken.
· Subjects will be made to lie comfortably.
· Inj.TT 0.5 ml IM stat will be given.
GROUP B:
· Informed consent will be taken.
· Lignocaine 2% subcutaneous 0.5 ml test dose will be given.
· Inj.TT 0.5 ml IM stat will be given.
· Subjects will be made to lie comfortably.
· Painting and draping will be done.
OPERATIVE PROCEDURE:
GROUP A:
· Maggots will be washed with sterile water.
· 10-12 Sterile Maggots per each square cm will be applied on the site of wound14, covered with air permeable dressing.
· Maggots are removed after 48 hours.
GROUP B:
· Under all aseptic precautions, Local anesthesia will be infiltrated around the wound. Slough will be removed using Allis forceps, Scissors, Artery forceps, Surgical blade, till appearance of healthy tissue, haemostasis will be attained.
POST - OPERATIVE PROCEDURE:
GROUP A:
· Proper bandaging will be done
· Maggots used for debridement will be put in sodium hypochlorite solution, sealed with biodegradable garbage bag and later will be incinerated.
GROUP B:
· Wound will be cleansed with normal saline, and proper bandaging will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
入选标准
- •1.Subjects of Grade I and Grade II Diabetic Foot Ulcer according to MEGGITT’S Classification of Diabetic Foot Ulcer.Irrespective of Gender,religion and occupation.
- •2.Diagnosed cases of Diabetic Foot Ulcers with 5cm× 4cm size (≤20cm2 area) and depth ≤ 1cm.
- •â€¢ Subjects with controlled Diabetes mellitus with HbA1c ≤ 6.5.
排除标准
- •â€¢ Subjects diagnosed as Diabetic Foot Ulcer with pre-gangrenous features and Gangrenous ulcers, Osteomyelitis, Abscess.
- •â€¢ Subjects diagnosed as Diabetic Foot Ulcer Suffering from systemic disorders like hypertension, HIV, HCV, HBsAg, STD, Tuberculosis, DVT.
- •â€¢ Subjects diagnosed as Diabetic Foot Ulcer Pregnant and lactating subjects.
- •â€¢ Subjects diagnosed as Diabetic Foot Ulcer Autoimmune disorders, genetic disorders.
- •â€¢ Subjects diagnosed as Diabetic Foot Ulcer with absence of Dorsalis pedis, Anterior and Posterior tibial pulse.
结局指标
主要结局
Attaining healthy granulation tissue and conversion of non healing ulcer to healing ulcer
时间窗: 1st 3rd 5th 7th 9th day
次要结局
- Reduction in the area of wound discharge & odour(1st 3rd 5th 7th 9th days)
研究者
Dr Prasann Patreppa Hanji
JSS Ayurveda Medical College and Hospital Mysuru