Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective study of participants with diabetic foot ulcers who will receive either maggot debridement therapy (MDT) or conventional dressing therapy (CDT). Wound healing time is the main outcome measure to compare the clinical efficacy of these two therapies. The investigators developed a hypothesis that MDT could achieve remarkable shorter time and better healing rate for wound closure when compared with CDT.
The investigators designed a prospective randomized study to compare the clinical safety and efficacy of maggot debridement therapy (MDT) and conventional dressing therapy (CDT). This study is scheduled from July 2016 to February 2017. Patients, aged from 18-80, who suffered from type 2 diabetic mellitus foot ulcers with Grade 1 or Grade 2 according to the Wagner classification could be the participants of this study. A sample of 138 participants was calculated based on the morbidity of diabetic foot ulcers, accounting for estimated 10% attrition rate. The glycemic control is important for the validity of study results. A specific team of endocrine doctors will manage the blood glucose of participants of two groups within the range of 7-10 mmol/L.
Participants will be allocated into MDT group and CDT group randomly according to the random number table. For MDT-participants, bio-bags containing sterilized, live, medicinal Lucilia sericata larvae will be placed on the wound of ulcers. For CDT-participants, conventional dressing (disinfected by iodophor, dressed by gauze ) will be performed ordinally. Every 3 days the procedures of two groups will be performed and wounds assessment will be done until the wounds closure is achieved. The wounds assessment, including measurement of the area of wound surface and bacterial culture, will be performed by a specific team of microsurgical doctors. The outcome measures include wound healing time (days) and the time negative bacterial culture occurs (days). The secondary outcome measures include the area of wound surface (cm2), treatment related pain, comfort of the dressing and adverse events.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maggot debridement therapy(MDT) | Experimental | Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed. |
|
| Conventional Dressing Therapy(CDT) | Active Comparator | Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maggot debridement therapy | Procedure | Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing time(days) | Wound complete closure is achieved. | From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first. |
| Measure | Description | Time Frame |
|---|---|---|
| Area of wounds (cm2) | Area of wounds are measured by transparency-based digital imaging method.Every 3/4 days when procedures(bio-bags/dressings) given. | From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first. |
| Adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun-Wei Zong | Contact | 8618098876071 | aweizone@163.com | |
| Shou-Yu Wang, Dr | Contact | 86041186110147 | wangshouyu666@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shou-Yu Wang, Dr | The First Affiliated Hospital of Dalian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Dalian Medical University | Enrolling by invitation | Dalian | Liaoning | 116000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25963495 | Background | Pinheiro MA, Ferraz JB, Junior MA, Moura AD, da Costa ME, Costa FJ, Neto VF, Neto RM, Gama RA. Use of maggot therapy for treating a diabetic foot ulcer colonized by multidrug resistant bacteria in Brazil. Indian J Med Res. 2015 Mar;141(3):340-2. doi: 10.4103/0971-5916.156628. | |
| 24841930 | Background | Sun X, Jiang K, Chen J, Wu L, Lu H, Wang A, Wang J. A systematic review of maggot debridement therapy for chronically infected wounds and ulcers. Int J Infect Dis. 2014 Aug;25:32-7. doi: 10.1016/j.ijid.2014.03.1397. Epub 2014 May 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096383 | Maggot Debridement Therapy |
| D009779 | Occlusive Dressings |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional Dressing Therapy | Procedure | Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed. |
|
|
Adverse events such as allergic reaction, infection, local pain and escape of the larvae from bio-bag.Every 3/4 day when procedures(bio-bags/dressings) given. |
| From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first. |
| Negative bacterial culture time (days) | The time that negative bacterial culture occured from recruitment. | From date of randomization until the date of the complete closure of wound or up to 12 weeks, whichever came first. |
| the First Affiliated Hospital of Dalian Medical University | Recruiting | Dalian | Liaoning | 116011 | China |
|
| 25478859 | Background | Shi E, Shofler D. Maggot debridement therapy: a systematic review. Br J Community Nurs. 2014 Dec;Suppl Wound Care:S6-13. doi: 10.12968/bjcn.2014.19.Sup12.S6. |
| 17975368 | Background | Sherman RA, Shapiro CE, Yang RM. Maggot therapy for problematic wounds: uncommon and off-label applications. Adv Skin Wound Care. 2007 Nov;20(11):602-10. doi: 10.1097/01.ASW.0000284943.70825.a8. |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |