Diabetic Foot UlcerPhase 3NCT02236793
A Phase 3 Clinical Trial to Assess the Effectiveness of BioChaperone PDGF-BB In the Treatment of Chronic Diabetic Foot Ulcer
A Phase 3 study testing BioChaperone PDGF-BB in people with Diabetic Foot Ulcer, run by Adocia at 32 sites in India.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- BioChaperone PDGF-BB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 252 participants
- Where
- 32 sitesIndia
- Study dates
- Dec 2014to Aug 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
India32 sites
B.J. Medical College and Civil Hospital
Ahmedabad
Dr Jivraj Mehta Smarak Health Foundation
Ahmedabad
Sangini Hospital
Ahmedabad
V.S. General Hospital & Sml NHL Municipal Medical College Sheth
Ahmedabad
Rajiv Gandhi Centre for Diabetes and Endocrinology
Aligarh
Govt Medical College and Hospital
Chandigarh
M.V. Hospital for Diabetes (P) Ltd
Chennai, Tamil Nadu
Dr V. Seshiah Diabetes Research Institute, Dr Balaji Diabetes Care centre
Chennai, Taminadu, 600 029
Sri Ramachandra Medial Centre
Chennai
The Madras Diabetes Research Foundation
Chennai
The Madras Medical Mission
Chennai
Mediciti Hospital
Hyderabad, Andhra Pradesh, 500 063
Gandhi Medical College & Hospital
Hyderabad
Nizam's Institute of Medical Sciences
Hyderabad
Sumana Hospital
Hyderabad
Surakshaka diabetic Centre(P) Ltd
Hyderabad
SMS Medical College & Attached Hospital
Jaipur
ILS Hospital
Kolkata
IPGME & R and SSKM Hospital
Kolkata
Nightingale Hospital
Kolkata
Rabindranath Tagore International Insitute of cardiac Sciences
Kolkata
Fortis Hospital Phase
Mohali
SL Raheja Hospital
Mumbai, Maharashtra, 400 016
Seth G.S. Medical College and K.E.M Hospital
Mumbai
Mysore Medical College & Research Institute
Mysore
Govt Medical college & Hospital Medical Square
Nagpur
Indira Gandhi Govt Medical College and Hospital
Nagpur
B.J. Govt. Medical College and Sassoon Hospital
Pune
Inamdar Multispeciality Hospital
Pune
Poona Hospital & Research Centre
Pune
Shree Giriraj Multispeciality Hospital
Rajkot
King Georges Hospital
Visakhapatnam
About this study
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
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).
- Conditions
- Diabetic Foot Ulcer
- Being tested
- BioChaperone PDGF-BB, Standard of Care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioChaperone PDGF-BBDrug
Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: BioChaperone PDGF-BB |
| 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 Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete wound closure.
Measured: 20 weeks
Secondary outcomes (5)
Time to achieve complete wound closure.
Measured: 20 weeks
Percentage reduction in total ulcer surface area at each visit.
Measured: 20 weeks
Incidence of complete wound healing
Measured: 10 weeks
Number of ulcer recurrence observed 12 weeks after wound healing.
Measured: 32 weeks
Treatment emergent adverse events.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Virchow Group
- Responsible party
- Sponsor
- Investigators
- Arun Bal, MD, Principal investigator, SL Raheja Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236793
- Sponsor's protocol ID
- BC1-CT4
- Status last verified
- Jun 2017
- First submitted
- 9 Sep 2014
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02236793
- Acronym / sponsor ID
- BC1-CT4
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Collaborators
- Virchow Group
- Study start
- Dec 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioChaperone PDGF-BB | Experimental | Drug: BioChaperone PDGF-BBBioChaperone 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 | Other: Standard of CareNormal saline solution applied every other day at the same volume for up to 20 weeks, associated with standard wound care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioChaperone PDGF-BB | Drug | BioChaperone PDGF-BB |
| Standard of Care | Other | Standard of Care |
Primary outcome
Incidence of complete wound closure.
Time frame: 20 weeks
5 secondary outcomes
Time to achieve complete wound closure.
Time frame: 20 weeks
Percentage reduction in total ulcer surface area at each visit.
Time frame: 20 weeks
Incidence of complete wound healing
Time frame: 10 weeks
Number of ulcer recurrence observed 12 weeks after wound healing.
Time frame: 32 weeks
Treatment emergent adverse events.
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Bal, MD principal investigator
SL Raheja Hospital
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BioChaperone PDGF-BB in people with Diabetic Foot Ulcer, run by Adocia at 32 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete wound closure. (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.