Foot Ulcer, DiabeticNCT01013792
A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
A study testing Wound Dressing in people with Foot Ulcer, Diabetic, run by Solventum US LLC at 6 sites in United States.
Trial summary
The primary objective is to: Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Is the subject 18 years of age or older?
- Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks?
- Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided?
- Does the subject show evidence of neuropathy?
- Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis?
- Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes?
Show all 12Show fewer
- Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)?
- Is the subject willing to have photos taken of their wound and permit use of the photos in publications?
- Has the subject or their legally authorized representative signed an Institutional Review Board approved informed consent document and authorized the use and disclosure of protected health information?
- Does the subject have adequate circulation to the foot as evidenced by an Ankle Brachial Index (ABI) of 0.8 - 1.2; or if the ABI is greater than 1.2, does the subject show toe pressures >40 mmHg, or transcutaneous oximetry (TcPO2) > 40 mm Hg, or does the subject show adequate circulation on an arterial Doppler study? (ABI or Doppler results must be < 45 days old.)
- Is the subject able to comply with the protocol requirements?
- If the subject is a woman of child bearing potential is she practicing an acceptable form of birth control as determined by the Investigator, and is she willing to have a pregnancy test?
Who cannot join
- Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
- Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year?
- Does the subject have an infection requiring systemic antibiotic treatment?
- Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)?
- Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.)
- Does the subject have Lupus or Crohn's disease?
Show all 15Show fewer
- Does the subject have an oxygen dependency?
- Has the subject received hyperbaric oxygen therapy within the previous 90 days?
- Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit?
- Does the subject have an active Charcot foot deformity of the foot presenting the ulcer?
- Has the subject received Dermagraft®, Apligraf, or any other biologically active wound care product, or used Regranex Gel®, KGF, TGFβ or another topical growth factor to the study ulcer within the 30 days prior to the Screening visit?
- Does the subject's wound require the use of topical silver, topical antibiotics, enzymatic debridement agents or other topical agents?
- Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?
- Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
- Has the subject received ultrasonic debridement or electrical stimulation within 7 days of the Screening Visit?
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Wyatt Payne, MD
Bay Pines, Florida, 33744
Vickie Driver, DPM
Boston, Massachusetts, 02118
Alex Reyzelman, DPM
Castro Valley, California, 94546
William Marston, MD
Chapel Hill, North Carolina, 27599
Terry Treadwell, MD
Montgomery, Alabama, 36111
Joseph Boykin, MD
Richmond, Virginia, 23220
About this study
Official title: A Multi-centered, Prospective, Randomized, Double-blinded, Comparison of an Investigational Non-adherent Dressing to 3M Tegaderm Matrix Dressing With PHI Technology in the Management of Non-healing Diabetic Foot Ulcers
The primary objective is to:
- Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.
Secondary objectives are to:
- Assess the adverse events that occur in subjects randomized to the investigational dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI technology.
- Assess the costs of using the investigational dressing compared to the Tegaderm Matrix Dressing with PHI technology.
- Assess and compare the impact that these dressings have on patients' quality of life.
- Assess the wound's biological response and pH to the study dressings.
Read the detailed description
The primary objective of this study is to compare the effect of an investigational, non-adherent dressing to a commercial wound dressing, 3M™ Tegaderm™ Matrix Dressing with PHI™ technology (Matrix dressing), in the management of diabetic foot ulcers. Subjects' wounds will be observed for a four week, pre-treatment period with wound assessments being made and samples of wound fluid and tissue collected and analyzed to characterize the wound. Following this pre-treatment observational stage, subjects continuing to meet inclusion/exclusion criteria will be randomly assigned, with stratification by center, wound size and wound duration, in either of two groups in the eight week treatment stage of the study. Subjects in one group will have their wound managed with an investigational non-adherent dressing, and subjects in the other group will have their wound managed with a Matrix dressing. At Visit 4 (start of the treatment stage of the study), subjects with a study wound that is less than 1 cm2 at this point will be dropped from the study. A second investigational device will be used to measure the pH of the wound, which will be compared to wound healing data.
Pre-treatment Stage Secondary Objectives
- To measure and compare changes in wound size and wound assessments with changes in wound biomarker levels, wound pH, microbial load, and changes in systemic levels of C-reactive protein and homocysteine.
- To measure and compare changes in wound biomarker levels, pH, and microbial load, and changes in systemic (blood) levels of C-reactive protein and homocysteine, looking for relationships.
Treatment Stage Secondary Objectives
- To measure and compare the incidence of adverse events experienced by subjects in each of the 2 treatment groups.
- To measure and compare the wound characteristics of each treatment group.
- To measure and compare the subjects' quality of life of each treatment group.
- To measure and compare the cost effectiveness of each treatment group.
- To measure and compare changes in wound size with changes in wound biomarker levels, pH, and microbial load; and changes in systemic (blood) levels of C-reactive protein and homocysteine.
- To measure and compare changes in wound biomarker levels, pH, microbial load, and changes in systemic levels of C-reactive protein and homocysteine, looking for relationships within treatment groups and overall.
- To assess the ease of using these dressing
Post-treatment Stage Secondary Objectives
Subjects whose wounds heal prior to Visit 12 are expected to have a follow-up appointment 12-14 weeks after their wound has healed. Subjects whose wounds do not heal by Visit 12 are expected to complete a follow-up appointment 12-14 weeks after their last appointment. The objectives of this are to determine the frequency of complete healing between the two treatment groups and to determine the number of wounds that had healed by the end of the treatment phase and remained healed for each group at the follow-up appointment.
The objective is to measure and compare the percentage of wounds healed by Visit 12 (or before) that remained healed at the follow-up appointment by treatment group.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- Wound Dressing
- Keywords
- Diabetic, Foot, Ulcer, Neuropathic, Tegaderm Matrix Dressing, DFU, Wound Care, PHI
- Medical subject headings
- Diabetic Foot, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound DressingDevice
Acetate mesh carrier with ointment (water, PEGs)
Wound DressingDevice
Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
| Study group | Role | What they receive |
|---|---|---|
| Non-adherent Wound Dressing | Experimental | The non-adherent dressing is the same as the Tegaderm Matrix dressing, with potassium chloride, rubidium chloride, calcium chloride, zinc chloride, potassium citrate and citric acid removed. This dressing is a Class I medical device (21 CFR Sec. 878.4020 Occlusive wound dressing) that is exempt from premarket notification procedures. Receives: Device: Wound Dressing |
| Tegaderm Matrix Dressing with PHI | Active comparator | A commercial wound dressing to be used per manufacturer's instructions for use. Receives: Device: Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit
A positive value indicates a reduction in area relative to baseline, while a negative value indicates an increase in area relative to baseline (at time of randomization), calculated as [(Baseline - Week 8)/Baseline] x 100%.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Expired study materials; low subject recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Foot Ulcer, DiabeticStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Joseph V Boykin, MD, Principal investigator, HCA Retreat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013792
- Sponsor's protocol ID
- 05-011091
- Status last verified
- Sep 2024
- First submitted
- 13 Nov 2009
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schultz G, Mozingo D, Romanelli M, Claxton K. Wound healing and TIME; new concepts and scientific applications. Wound Repair Regen. 2005 Jul-Aug;13(4 Suppl):S1-11. doi: 10.1111/j.1067-1927.2005.1304S1.x. No abstract available.
PubMed 16008735Keast DH, Bowering CK, Evans AW, Mackean GL, Burrows C, D'Souza L. MEASURE: A proposed assessment framework for developing best practice recommendations for wound assessment. Wound Repair Regen. 2004 May-Jun;12(3 Suppl):S1-17. doi: 10.1111/j.1067-1927.2004.0123S1.x.
PubMed 15230830Mustoe T. Understanding chronic wounds: a unifying hypothesis on their pathogenesis and implications for therapy. Am J Surg. 2004 May;187(5A):65S-70S. doi: 10.1016/S0002-9610(03)00306-4.
PubMed 15147994Falanga V. The chronic wound: impaired healing and solutions in the context of wound bed preparation. Blood Cells Mol Dis. 2004 Jan-Feb;32(1):88-94. doi: 10.1016/j.bcmd.2003.09.020.
PubMed 14757419Xu L, McLennan SV, Lo L, Natfaji A, Bolton T, Liu Y, Twigg SM, Yue DK. Bacterial load predicts healing rate in neuropathic diabetic foot ulcers. Diabetes Care. 2007 Feb;30(2):378-80. doi: 10.2337/dc06-1383. No abstract available.
PubMed 17259515Blakytny R, Jude E. The molecular biology of chronic wounds and delayed healing in diabetes. Diabet Med. 2006 Jun;23(6):594-608. doi: 10.1111/j.1464-5491.2006.01773.x.
PubMed 16759300Steed DL. Wound-healing trajectories. Surg Clin North Am. 2003 Jun;83(3):547-55, vi-vii. doi: 10.1016/S0039-6109(02)00208-6.
PubMed 12822725Robson MC, Hill DP, Woodske ME, Steed DL. Wound healing trajectories as predictors of effectiveness of therapeutic agents. Arch Surg. 2000 Jul;135(7):773-7. doi: 10.1001/archsurg.135.7.773.
PubMed 10896369Margolis DJ, Gelfand JM, Hoffstad O, Berlin JA. Surrogate end points for the treatment of diabetic neuropathic foot ulcers. Diabetes Care. 2003 Jun;26(6):1696-700. doi: 10.2337/diacare.26.6.1696.
PubMed 12766096Gelfand JM, Hoffstad O, Margolis DJ. Surrogate endpoints for the treatment of venous leg ulcers. J Invest Dermatol. 2002 Dec;119(6):1420-5. doi: 10.1046/j.1523-1747.2002.19629.x.
PubMed 12485449Sheehan P, Jones P, Giurini JM, Caselli A, Veves A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):239S-244S. doi: 10.1097/01.prs.0000222891.74489.33.
PubMed 16799391Steed DL, Hill DP, Woodske ME, Payne WG, Robson MC. Wound-healing trajectories as outcome measures of venous stasis ulcer treatment. Int Wound J. 2006 Mar;3(1):40-7. doi: 10.1111/j.1742-4801.2006.00178.x.
PubMed 16650209Kantor J, Margolis DJ. A multicentre study of percentage change in venous leg ulcer area as a prognostic index of healing at 24 weeks. Br J Dermatol. 2000 May;142(5):960-4. doi: 10.1046/j.1365-2133.2000.03478.x.
PubMed 10809855Greener B, Hughes AA, Bannister NP, Douglass J. Proteases and pH in chronic wounds. J Wound Care. 2005 Feb;14(2):59-61. doi: 10.12968/jowc.2005.14.2.26739. No abstract available.
PubMed 15739652Karim RB, Brito BL, Dutrieux RP, Lassance FP, Hage JJ. MMP-2 assessment as an indicator of wound healing: A feasibility study. Adv Skin Wound Care. 2006 Jul-Aug;19(6):324-7. doi: 10.1097/00129334-200607000-00011.
PubMed 16885646
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centered, Prospective, Randomized, Double-blinded, Comparison of an Investigational Non-adherent Dressing to 3M Tegaderm Matrix Dressing With PHI Technology in the Management of Non-healing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01013792
- Acronym / sponsor ID
- 05-011091
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- Diabetic, Foot, Ulcer, Neuropathic, Tegaderm Matrix Dressing, DFU, Wound Care, PHI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Expired study materials; low subject recruitment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Nov 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 16 Nov 2009 (estimated)
- Results
- Posted 23 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to:
- Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.
Secondary objectives are to:
- Assess the adverse events that occur in subjects randomized to the investigational dressing in comparison to subjects randomized to the Tegaderm Matrix Dressing with PHI technology.
- Assess the costs of using the investigational dressing compared to the Tegaderm Matrix Dressing with PHI technology.
- Assess and compare the impact that these dressings have on patients' quality of life.
- Assess the wound's biological response and pH to the study dressings.
Detailed description
The primary objective of this study is to compare the effect of an investigational, non-adherent dressing to a commercial wound dressing, 3M™ Tegaderm™ Matrix Dressing with PHI™ technology (Matrix dressing), in the management of diabetic foot ulcers. Subjects' wounds will be observed for a four week, pre-treatment period with wound assessments being made and samples of wound fluid and tissue collected and analyzed to characterize the wound. Following this pre-treatment observational stage, subjects continuing to meet inclusion/exclusion criteria will be randomly assigned, with stratification by center, wound size and wound duration, in either of two groups in the eight week treatment stage of the study. Subjects in one group will have their wound managed with an investigational non-adherent dressing, and subjects in the other group will have their wound managed with a Matrix dressing. At Visit 4 (start of the treatment stage of the study), subjects with a study wound that is less than 1 cm2 at this point will be dropped from the study. A second investigational device will be used to measure the pH of the wound, which will be compared to wound healing data.
Pre-treatment Stage Secondary Objectives
- To measure and compare changes in wound size and wound assessments with changes in wound biomarker levels, wound pH, microbial load, and changes in systemic levels of C-reactive protein and homocysteine.
- To measure and compare changes in wound biomarker levels, pH, and microbial load, and changes in systemic (blood) levels of C-reactive protein and homocysteine, looking for relationships.
Treatment Stage Secondary Objectives
- To measure and compare the incidence of adverse events experienced by subjects in each of the 2 treatment groups.
- To measure and compare the wound characteristics of each treatment group.
- To measure and compare the subjects' quality of life of each treatment group.
- To measure and compare the cost effectiveness of each treatment group.
- To measure and compare changes in wound size with changes in wound biomarker levels, pH, and microbial load; and changes in systemic (blood) levels of C-reactive protein and homocysteine.
- To measure and compare changes in wound biomarker levels, pH, microbial load, and changes in systemic levels of C-reactive protein and homocysteine, looking for relationships within treatment groups and overall.
- To assess the ease of using these dressing
Post-treatment Stage Secondary Objectives
Subjects whose wounds heal prior to Visit 12 are expected to have a follow-up appointment 12-14 weeks after their wound has healed. Subjects whose wounds do not heal by Visit 12 are expected to complete a follow-up appointment 12-14 weeks after their last appointment. The objectives of this are to determine the frequency of complete healing between the two treatment groups and to determine the number of wounds that had healed by the end of the treatment phase and remained healed for each group at the follow-up appointment.
The objective is to measure and compare the percentage of wounds healed by Visit 12 (or before) that remained healed at the follow-up appointment by treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-adherent Wound Dressing | Experimental | Device: Wound DressingThe non-adherent dressing is the same as the Tegaderm Matrix dressing, with potassium chloride, rubidium chloride, calcium chloride, zinc chloride, potassium citrate and citric acid removed. This dressing is a Class I medical device (21 CFR Sec. 878.4020 Occlusive wound dressing) that is exempt from premarket notification procedures. |
| Tegaderm Matrix Dressing with PHI | Active comparator | Device: Wound DressingA commercial wound dressing to be used per manufacturer's instructions for use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Is the subject 18 years of age or older?
- Does the subject have a chronic full thickness diabetic foot ulcer (DFU) inferior to the malleolus that has been present for a minimum of four (4) weeks?
- Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided?
- Does the subject show evidence of neuropathy?
- Is the subject's wound free of tunneling and showing no exposed periosteum or bone and free of clinical infection defined as the presence of local signs and symptoms including purulence, warmth, tenderness, pain, induration, cellulitis, bullae, crepitus, abscess, fasciitis and osteomyelitis?
Key exclusion criteria (15 listed)
- Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
- Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year?
- Does the subject have an infection requiring systemic antibiotic treatment?
- Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)?
- Is the subject currently using systemic steroids, or have they used systemic steroids within the previous 2 weeks, or are they projected to require systemic steroid use during the study as evidenced by a history of chronic systemic steroid use? (Topical steroids (except on the study extremity) and steroid inhalants will be allowed in the study.)
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 |
|---|---|---|
| Wound DressingAcetate mesh carrier with ointment (water, PEGs) | Device | Non-adherent Wound Dressing |
| Wound DressingAcetate mesh carrier with ointment (water, PEGs, cations, citric acid) | Device | Tegaderm Matrix Dressing with PHI |
Primary outcome
Percent Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit
Time frame: up to 8 weeks
A positive value indicates a reduction in area relative to baseline, while a negative value indicates an increase in area relative to baseline (at time of randomization), calculated as [(Baseline - Week 8)/Baseline] x 100%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16008735Schultz G, Mozingo D, Romanelli M, Claxton K. Wound healing and TIME; new concepts and scientific applications. Wound Repair Regen. 2005 Jul-Aug;13(4 Suppl):S1-11. doi: 10.1111/j.1067-1927.2005.1304S1.x. No abstract available.
- Background: PubMed 15230830Keast DH, Bowering CK, Evans AW, Mackean GL, Burrows C, D'Souza L. MEASURE: A proposed assessment framework for developing best practice recommendations for wound assessment. Wound Repair Regen. 2004 May-Jun;12(3 Suppl):S1-17. doi: 10.1111/j.1067-1927.2004.0123S1.x.
- Background: PubMed 15147994Mustoe T. Understanding chronic wounds: a unifying hypothesis on their pathogenesis and implications for therapy. Am J Surg. 2004 May;187(5A):65S-70S. doi: 10.1016/S0002-9610(03)00306-4.
- Background: PubMed 14757419Falanga V. The chronic wound: impaired healing and solutions in the context of wound bed preparation. Blood Cells Mol Dis. 2004 Jan-Feb;32(1):88-94. doi: 10.1016/j.bcmd.2003.09.020.
- Background: PubMed 17259515Xu L, McLennan SV, Lo L, Natfaji A, Bolton T, Liu Y, Twigg SM, Yue DK. Bacterial load predicts healing rate in neuropathic diabetic foot ulcers. Diabetes Care. 2007 Feb;30(2):378-80. doi: 10.2337/dc06-1383. No abstract available.
- Background: PubMed 16759300Blakytny R, Jude E. The molecular biology of chronic wounds and delayed healing in diabetes. Diabet Med. 2006 Jun;23(6):594-608. doi: 10.1111/j.1464-5491.2006.01773.x.
- Background: PubMed 12822725Steed DL. Wound-healing trajectories. Surg Clin North Am. 2003 Jun;83(3):547-55, vi-vii. doi: 10.1016/S0039-6109(02)00208-6.
- Background: PubMed 10896369Robson MC, Hill DP, Woodske ME, Steed DL. Wound healing trajectories as predictors of effectiveness of therapeutic agents. Arch Surg. 2000 Jul;135(7):773-7. doi: 10.1001/archsurg.135.7.773.
- Background: PubMed 12766096Margolis DJ, Gelfand JM, Hoffstad O, Berlin JA. Surrogate end points for the treatment of diabetic neuropathic foot ulcers. Diabetes Care. 2003 Jun;26(6):1696-700. doi: 10.2337/diacare.26.6.1696.
- Background: PubMed 12485449Gelfand JM, Hoffstad O, Margolis DJ. Surrogate endpoints for the treatment of venous leg ulcers. J Invest Dermatol. 2002 Dec;119(6):1420-5. doi: 10.1046/j.1523-1747.2002.19629.x.
- Background: PubMed 16799391Sheehan P, Jones P, Giurini JM, Caselli A, Veves A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):239S-244S. doi: 10.1097/01.prs.0000222891.74489.33.
- Background: PubMed 16650209Steed DL, Hill DP, Woodske ME, Payne WG, Robson MC. Wound-healing trajectories as outcome measures of venous stasis ulcer treatment. Int Wound J. 2006 Mar;3(1):40-7. doi: 10.1111/j.1742-4801.2006.00178.x.
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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.
Joseph V Boykin, MD principal investigator
HCA Retreat Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound Dressing in people with Foot Ulcer, Diabetic, run by Solventum US LLC at 6 sites 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 12 inclusion and 15 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: stopped early, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Diabetic Foot Ulcer Area Reduction From Baseline to Last Treatment Visit (time frame: up to 8 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 NCT01013792, which also lists 30 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 2 Oct 2024.