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| Name | Class |
|---|---|
| Virchow Group | INDUSTRY |
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The present clinical trial is designed to assess the effectiveness of BioChaperone PDGF-BB applied at 4 µg/cm² every other day for up to 20 weeks and associated to Standard of Care as compared to Standard of Care alone for the treatment of neuropathic and neurovascular diabetic foot ulcers.(In order to ensure the double-blinding of the treatments, a sterile normal saline solution presented in the same multi-dose spray vials than BioChaperone PDGF-BB will be applied on patients of the control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioChaperone PDGF-BB | Experimental | BioChaperone PDGF-BB administered every other day at the dose of 4µg/cm² for 20 weeks or until wound closure, associated with Standard of Care |
|
| Standard of Care | Placebo Comparator | Normal saline solution applied every other day at the same volume for up to 20 weeks, associated with standard wound care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioChaperone PDGF-BB | Drug |
| ||
| Standard of Care |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complete wound closure. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to achieve complete wound closure. | 20 weeks | |
| Percentage reduction in total ulcer surface area at each visit. | 20 weeks | |
| Incidence of complete wound healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun Bal, MD | SL Raheja Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mediciti Hospital | Hyderabad | Andhra Pradesh | 500 063 | India | ||
| SL Raheja Hospital |
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|
| 10 weeks |
| Number of ulcer recurrence observed 12 weeks after wound healing. | 32 weeks |
| Treatment emergent adverse events. | 52 weeks |
| Mumbai |
| Maharashtra |
| 400 016 |
| India |
| M.V. Hospital for Diabetes (P) Ltd | Chennai | Tamil Nadu | India |
| Dr V. Seshiah Diabetes Research Institute, Dr Balaji Diabetes Care centre | Chennai | Taminadu | 600 029 | India |
| B.J. Medical College and Civil Hospital | Ahmedabad | India |
| Dr Jivraj Mehta Smarak Health Foundation | Ahmedabad | India |
| Sangini Hospital | Ahmedabad | India |
| V.S. General Hospital & Sml NHL Municipal Medical College Sheth | Ahmedabad | India |
| Rajiv Gandhi Centre for Diabetes and Endocrinology | Aligarh | India |
| Govt Medical College and Hospital | Chandigarh | India |
| Sri Ramachandra Medial Centre | Chennai | India |
| The Madras Diabetes Research Foundation | Chennai | India |
| The Madras Medical Mission | Chennai | India |
| Gandhi Medical College & Hospital | Hyderabad | India |
| Nizam's Institute of Medical Sciences | Hyderabad | India |
| Sumana Hospital | Hyderabad | India |
| Surakshaka diabetic Centre(P) Ltd | Hyderabad | India |
| SMS Medical College & Attached Hospital | Jaipur | India |
| ILS Hospital | Kolkata | India |
| IPGME & R and SSKM Hospital | Kolkata | India |
| Nightingale Hospital | Kolkata | India |
| Rabindranath Tagore International Insitute of cardiac Sciences | Kolkata | India |
| Fortis Hospital Phase | Mohali | India |
| Seth G.S. Medical College and K.E.M Hospital | Mumbai | India |
| Mysore Medical College & Research Institute | Mysore | India |
| Govt Medical college & Hospital Medical Square | Nagpur | India |
| Indira Gandhi Govt Medical College and Hospital | Nagpur | India |
| B.J. Govt. Medical College and Sassoon Hospital | Pune | India |
| Inamdar Multispeciality Hospital | Pune | India |
| Poona Hospital & Research Centre | Pune | India |
| Shree Giriraj Multispeciality Hospital | Rajkot | India |
| King Georges Hospital | Visakhapatnam | India |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| 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 |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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