Diabetic FootPhase 2NCT02092870
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
A Phase 2 study testing Adipose derived stem cells in people with Diabetic Foot and Venous Ulcer, run by Tower Outpatient Surgical Center at 1 site in United States.
Trial summary
Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Venous Ulcer, Pressure Ulcer
- What is being tested?
- Adipose derived stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 9 Sep 2019
- Phase
- Phase 2
- 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
- Female or male patient aged ≥ 18
- With diagnosis of diabetic or other chronic wound
- Grade 1 or 2 wound on the Wagner Scale
- Ulcer with a surface area comprised greater than 4 cm2 included (after mechanical debridement of the ulcer)
- For subjects with more than one wound that meet these criteria, all qualifying wounds may be treated
- Patient's wound has been refractory to standard of care (no measureable signs of healing for at least 30 days)
- Patient has adequate (>200cc) abdominal or other subcutaneous adipose tissue accessible by syringe-based lipoharvest
- Patient has activated platelet thromboplastin time (aPTT) of < 1.6x the mean normal reference interval at the time of the lipoharvest procedure and no contraindication to lipoharvest
Who cannot join
- Typical Charcot's foot
- Presence of osteitis (eq Br osteomyelitis) at the inclusion visit (evidenced with a radiological lesion facing the wound [bone erosion or disappearance of the cortical bone]) as determined by MRI
- Clinical evidence of uncontrolled infection at the inclusion visit
- Patient not eligible for syringe-based lipoharvest of at least 200cc of subcutaneous adipose tissue
- Subjects with cancerous or pre-cancerous lesions in the area to be treated
- Patient with working activity who cannot be on sick-leave during the study period
Show all 14Show fewer
- Patient suffering from a psychiatric disorder not treated
- Clinical evidence of gangrene on any part of the affected foot
- Patient receiving corticosteroids, NSAIDs, immunosuppressive or cytotoxic agents, all systemic agents that can affect wound repair or any treatment that might interfere with the assessment of the study treatment
- Pregnant or nursing females
- Patient receiving dialysis for renal insufficiency or who have severe renal dysfunction
- Patient who cannot have an off-loading method
- Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this study
- Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Tower Outpatient Surgical Center
Los Angeles, California, 90048
About this study
Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.
Read the detailed description
In an attempt to explore the contribution of Adipose Derived Stem Cells (ASCs) to chronic wound healing, we will investigate the effects of injecting ASCs into the periphery and debrided surfaces of chronic wounds. Our goal is to achieve healing in two months, and for the wounds to stay healed for the following two weeks.
- Conditions
- Diabetic Foot, Venous Ulcer, Pressure Ulcer
- Being tested
- Adipose derived stem cells
- Keywords
- Chronic Wounds, Diabetes, Adipose Derived Stem Cells, Diabetic Foot
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose derived stem cellsDrug
Also called stem cells, stromal vascular fraction
ASCs harvested from autologous lipoaspirate
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Chronic Wound | Experimental | Patients will receive a single treatment with ASCs in the form of multiple injections of cells within and immediately surrounding the wound. Cells will be delivered using a 1 cc syringe with an appropriate gauge and length needle. Each injection will have a volume less than 250 micro-liters. The number of injections will be determined by the surgeon as a function of total wound volume. Receives: Drug: Adipose derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in wound size from baseline at 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tower Outpatient Surgical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel A. Aronowitz, M.D., Principal investigator, Tower Multispecialty Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092870
- Sponsor's protocol ID
- 001
- Status last verified
- Sep 2019
- First submitted
- 18 Mar 2014
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. doi: 10.2337/diacare.21.9.1414.
PubMed 9727886Williams R, Van Gaal L, Lucioni C; CODE-2 Advisory Board. Assessing the impact of complications on the costs of Type II diabetes. Diabetologia. 2002 Jul;45(7):S13-7. doi: 10.1007/s00125-002-0859-9. Epub 2002 Jun 12.
PubMed 12136406Reiber GE. The epidemiology of diabetic foot problems. Diabet Med. 1996;13 Suppl 1:S6-11. No abstract available.
PubMed 8741821Reiber GE, Vileikyte L, Boyko EJ, del Aguila M, Smith DG, Lavery LA, Boulton AJ. Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care. 1999 Jan;22(1):157-62. doi: 10.2337/diacare.22.1.157.
PubMed 10333919Hanft JR, Surprenant MS. Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis. J Foot Ankle Surg. 2002 Sep-Oct;41(5):291-9. doi: 10.1016/s1067-2516(02)80047-3.
PubMed 12400712Marston WA, Hanft J, Norwood P, Pollak R; Dermagraft Diabetic Foot Ulcer Study Group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003 Jun;26(6):1701-5. doi: 10.2337/diacare.26.6.1701.
PubMed 12766097Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998 May;21(5):822-7. doi: 10.2337/diacare.21.5.822.
PubMed 9589248Damour O, Gueugniaud PY, Berthin-Maghit M, Rousselle P, Berthod F, Sahuc F, Collombel C. A dermal substrate made of collagen--GAG--chitosan for deep burn coverage: first clinical uses. Clin Mater. 1994;15(4):273-6. doi: 10.1016/0267-6605(94)90057-4.
PubMed 10147171
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
- ClinicalTrials.gov ID
- NCT02092870
- Acronym / sponsor ID
- 001
- Conditions
- Diabetic Foot, Venous Ulcer, Pressure Ulcer
- Keywords
- Chronic Wounds, Diabetes, Adipose Derived Stem Cells, Diabetic Foot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tower Outpatient Surgical CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 20 Mar 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.
Our study aims to explore the effects of Adipose Derived Stem Cells (ASCs) on chronic wounds.
Detailed description
In an attempt to explore the contribution of Adipose Derived Stem Cells (ASCs) to chronic wound healing, we will investigate the effects of injecting ASCs into the periphery and debrided surfaces of chronic wounds. Our goal is to achieve healing in two months, and for the wounds to stay healed for the following two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of Chronic Wound | Experimental | Drug: Adipose derived stem cellsPatients will receive a single treatment with ASCs in the form of multiple injections of cells within and immediately surrounding the wound. Cells will be delivered using a 1 cc syringe with an appropriate gauge and length needle. Each injection will have a volume less than 250 micro-liters. The number of injections will be determined by the surgeon as a function of total wound volume. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female or male patient aged ≥ 18
- With diagnosis of diabetic or other chronic wound
- Grade 1 or 2 wound on the Wagner Scale
- Ulcer with a surface area comprised greater than 4 cm2 included (after mechanical debridement of the ulcer)
- For subjects with more than one wound that meet these criteria, all qualifying wounds may be treated
Key exclusion criteria (14 listed)
- Typical Charcot's foot
- Presence of osteitis (eq Br osteomyelitis) at the inclusion visit (evidenced with a radiological lesion facing the wound [bone erosion or disappearance of the cortical bone]) as determined by MRI
- Clinical evidence of uncontrolled infection at the inclusion visit
- Patient not eligible for syringe-based lipoharvest of at least 200cc of subcutaneous adipose tissue
- Subjects with cancerous or pre-cancerous lesions in the area to be treated
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 |
|---|---|---|
| Adipose derived stem cellsAlso: stem cells, stromal vascular fractionASCs harvested from autologous lipoaspirate | Drug | Treatment of Chronic Wound |
Primary outcome
Percent change in wound size from baseline at 12 weeks
Time frame: 12 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 11 Sep 2019.
- Background: PubMed 9727886King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025: prevalence, numerical estimates, and projections. Diabetes Care. 1998 Sep;21(9):1414-31. doi: 10.2337/diacare.21.9.1414.
- Background: PubMed 12136406Williams R, Van Gaal L, Lucioni C; CODE-2 Advisory Board. Assessing the impact of complications on the costs of Type II diabetes. Diabetologia. 2002 Jul;45(7):S13-7. doi: 10.1007/s00125-002-0859-9. Epub 2002 Jun 12.
- Background: PubMed 8741821Reiber GE. The epidemiology of diabetic foot problems. Diabet Med. 1996;13 Suppl 1:S6-11. No abstract available.
- Background: PubMed 10333919Reiber GE, Vileikyte L, Boyko EJ, del Aguila M, Smith DG, Lavery LA, Boulton AJ. Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care. 1999 Jan;22(1):157-62. doi: 10.2337/diacare.22.1.157.
- Background: PubMed 12400712Hanft JR, Surprenant MS. Healing of chronic foot ulcers in diabetic patients treated with a human fibroblast-derived dermis. J Foot Ankle Surg. 2002 Sep-Oct;41(5):291-9. doi: 10.1016/s1067-2516(02)80047-3.
- Background: PubMed 12766097Marston WA, Hanft J, Norwood P, Pollak R; Dermagraft Diabetic Foot Ulcer Study Group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003 Jun;26(6):1701-5. doi: 10.2337/diacare.26.6.1701.
- Background: PubMed 9589248Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998 May;21(5):822-7. doi: 10.2337/diacare.21.5.822.
- Background: PubMed 10147171Damour O, Gueugniaud PY, Berthin-Maghit M, Rousselle P, Berthod F, Sahuc F, Collombel C. A dermal substrate made of collagen--GAG--chitosan for deep burn coverage: first clinical uses. Clin Mater. 1994;15(4):273-6. doi: 10.1016/0267-6605(94)90057-4.
- Related InfoLink provided by the sponsor.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Joel A. Aronowitz, M.D. principal investigator
Tower Multispecialty Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adipose derived stem cells in people with Diabetic Foot and Venous Ulcer, run by Tower Outpatient Surgical Center at 1 site in United States.
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 8 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percent change in wound size from baseline at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02092870, which also lists 8 linked publications.
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 11 Sep 2019.