A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer

Diabetic Foot Ulcer Clinical Trial

Official title:

Phase III, Multicentre, Randomized, Parallel Group, Double Blinded and Control Group Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236793
• Other study ID #: BC1-CT4
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2014
• Last updated: June 28, 2017
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: June 2017
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus

• Patient with a single ulcer on the treated feet

• Patient able and willing to provide informed consent

• Patient able and willing to comply with protocol visits and procedure

• Patient willing to use an off-loading method during the whole duration of the study

• Full-thickness plantar, lateral or dorsal ulcer of the extremity (below the malleolus), excluding inter-digits ulcer (web spaces), extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined by University of Texas Diabetic Wound Classification or Grade 1 according to Wagner classification)

• Chronic ulcer of at least six weeks despite appropriate wound care

• Ulcer area measured with the formula Length x Width x 0.8 following sharp debridement, of 1 to 10 cm², both inclusive

• Well controlled infection or cellulitis (systemic antibiotherapy) before Baseline Visit

• Peripheral neuropathy as assessed by Semmes- Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold).

• Ankle brachial pressure index > 0.60 and <1.3

• Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing

Exclusion Criteria:

• Inter digit ulcers

• Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers

• Charcot foot.

• Wound originated from amputation bed

• Active ulcer infection assessed by clinical examination and radiography if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement and controlled by standard wound care.

• Active osteomyelitis affecting the area of the target ulcer

• Poorly controlled diabetes (uncontrolled glycemia: HbA1c% >= 10%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL)

• Known connective tissue or malignant disease

• Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy

• Use of investigational drug/device or growth factor within 30 days

• Topical application of any advance wound care on this wound (antiseptics, antibiotics, debriders, enzyme) within 7 days

• Vascular reconstruction within 8 weeks

• Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason.

• A history of severe cerebrovascular events

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Drug:
• BioChaperone PDGF-BB

Other:
• Standard of Care

Locations

Country	Name	City	State
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	Dr V. Seshiah Diabetes Research Institute, Dr Balaji Diabetes Care centre	Chennai	Taminadu
India	M.V. Hospital for Diabetes (P) Ltd	Chennai	Tamilnadu
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	Mediciti Hospital	Hyderabad	Andhra Pradesh
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	SL Raheja Hospital	Mumbai	Maharashtra
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	Vishakapatnam

Sponsors (2)

Lead Sponsor	Collaborator
Adocia	Virchow Group

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complete wound closure.		20 weeks
Secondary	Time to achieve complete wound closure.		20 weeks
Secondary	Percentage reduction in total ulcer surface area at each visit.		20 weeks
Secondary	Incidence of complete wound healing		10 weeks
Secondary	Number of ulcer recurrence observed 12 weeks after wound healing.		32 weeks
Secondary	Treatment emergent adverse events.		52 weeks