A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
NCT ID: NCT01013792
Last Updated: 2024-10-02
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-11-30
Study Completion Date
2012-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds
NCT00837096
Diabetic Amputation Foot Wound
TERMINATED
NA
Effect of Platelet Concentrate in Treatment of Diabetic Ulcers
NCT00215735
Diabetes
TERMINATED
NA
An Evaluation of a Fibrillar Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds
NCT03723577
Wound
WITHDRAWN
NA
Comparing the Efficacy of the ConvaTec Engenex® Negative Pressure Wound Therapy Device to Moist Wound Therapy
NCT01108276
Diabetes
Foot Wound
WITHDRAWN
PHASE4
Evaluation of Topical Wound Oxygen (two2) Therapy
NCT00871312
Diabetic Ulcer
TERMINATED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
1. 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.
2. 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
1. To measure and compare the incidence of adverse events experienced by subjects in each of the 2 treatment groups.
2. To measure and compare the wound characteristics of each treatment group.
3. To measure and compare the subjects' quality of life of each treatment group.
4. To measure and compare the cost effectiveness of each treatment group.
5. 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.
6. 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.
7. 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.
Pre-treatment Stage Secondary Objectives
1. 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.
2. 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
1. To measure and compare the incidence of adverse events experienced by subjects in each of the 2 treatment groups.
2. To measure and compare the wound characteristics of each treatment group.
3. To measure and compare the subjects' quality of life of each treatment group.
4. To measure and compare the cost effectiveness of each treatment group.
5. 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.
6. 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.
7. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Foot Ulcer, Diabetic
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-adherent Wound Dressing
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.
Group Type
EXPERIMENTAL
Wound Dressing
Intervention Type
DEVICE
Acetate mesh carrier with ointment (water, PEGs)
Tegaderm Matrix Dressing with PHI
A commercial wound dressing to be used per manufacturer's instructions for use.
Group Type
ACTIVE_COMPARATOR
Wound Dressing
Intervention Type
DEVICE
Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Wound Dressing
Acetate mesh carrier with ointment (water, PEGs)
Intervention Type
DEVICE
Wound Dressing
Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Is the subject 18 years of age or older?
2. 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?
3. Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided?
4. Does the subject show evidence of neuropathy?
5. 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?
6. Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes?
7. Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)?
8. Is the subject willing to have photos taken of their wound and permit use of the photos in publications?
9. 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?
10. 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.)
11. Is the subject able to comply with the protocol requirements?
12. 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?
2. 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?
3. Does the diabetic foot ulcer measure greater than 1.0 cm2 and less than 25.0 cm2 after the wound is debrided?
4. Does the subject show evidence of neuropathy?
5. 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?
6. Is the study wound able to be off loaded or achieve pressure relief and permit daily dressing changes?
7. Is the subject willing to have three (3) wound biopsies taken (Visit 0, 4 and 8)?
8. Is the subject willing to have photos taken of their wound and permit use of the photos in publications?
9. 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?
10. 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.)
11. Is the subject able to comply with the protocol requirements?
12. 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?
Exclusion Criteria
1. Is the subject pregnant or breast feeding or have they given birth within the 3 weeks preceding the screening visit?
2. Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year?
3. Does the subject have an infection requiring systemic antibiotic treatment?
4. Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)?
5. 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.)
6. Does the subject have Lupus or Crohn's disease?
7. Does the subject have an oxygen dependency?
8. Has the subject received hyperbaric oxygen therapy within the previous 90 days?
9. Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit?
10. Does the subject have an active Charcot foot deformity of the foot presenting the ulcer?
11. 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?
12. Does the subject's wound require the use of topical silver, topical antibiotics, enzymatic debridement agents or other topical agents?
13. Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?
14. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
15. Has the subject received ultrasonic debridement or electrical stimulation within 7 days of the Screening Visit?
2. Has the subject been diagnosed with a malignant disease and received chemotherapy or treatment for a malignancy within the past 1 year?
3. Does the subject have an infection requiring systemic antibiotic treatment?
4. Has the subject ever received radiation therapy or other local therapy for malignancy at the extremity where the wound is located (from patient history)?
5. 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.)
6. Does the subject have Lupus or Crohn's disease?
7. Does the subject have an oxygen dependency?
8. Has the subject received hyperbaric oxygen therapy within the previous 90 days?
9. Has the subject had vascular surgery relating to the wound within 30 days prior to the Screening Visit?
10. Does the subject have an active Charcot foot deformity of the foot presenting the ulcer?
11. 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?
12. Does the subject's wound require the use of topical silver, topical antibiotics, enzymatic debridement agents or other topical agents?
13. Has the subject been enrolled in any investigational study within 30 days of the Screening Visit?
14. Does the subject have any medical condition that in the opinion of the investigator should exclude him/her from participating in the study?
15. Has the subject received ultrasonic debridement or electrical stimulation within 7 days of the Screening Visit?
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
3M
INDUSTRY
Sponsor Role
collaborator
Solventum US LLC
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joseph V Boykin, MD
Role: PRINCIPAL_INVESTIGATOR
HCA Retreat Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Terry Treadwell, MD
Montgomery, Alabama, United States
Site Status
Alex Reyzelman, DPM
Castro Valley, California, United States
Site Status
Wyatt Payne, MD
Bay Pines, Florida, United States
Site Status
Vickie Driver, DPM
Boston, Massachusetts, United States
Site Status
William Marston, MD
Chapel Hill, North Carolina, United States
Site Status
Joseph Boykin, MD
Richmond, Virginia, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
Keast 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.
Reference Type
BACKGROUND
Mustoe 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.
Reference Type
BACKGROUND
Falanga 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.
Reference Type
BACKGROUND
Xu 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.
Reference Type
BACKGROUND
Blakytny 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.
Reference Type
BACKGROUND
Steed DL. Wound-healing trajectories. Surg Clin North Am. 2003 Jun;83(3):547-55, vi-vii. doi: 10.1016/S0039-6109(02)00208-6.
Reference Type
BACKGROUND
Robson 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.
Reference Type
BACKGROUND
Margolis 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.
Reference Type
BACKGROUND
Gelfand 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.
Reference Type
BACKGROUND
Sheehan 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.
Reference Type
BACKGROUND
Steed 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.
Reference Type
BACKGROUND
Kantor 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.
Reference Type
BACKGROUND
Greener 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.
Reference Type
BACKGROUND
Karim 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.
Reference Type
BACKGROUND
Pirayesh A, Dessy LA, Rogge FJ, Hoeksema HJ, Sinove YM, Dall' Antonia A, Jawad MA, Gilbert PM, Rubino C, Scuderi N, Blondeel R, Monstrey S. The efficacy of a polyhydrated ionogen impregnated dressing in the treatment of recalcitrant diabetic foot ulcers: a multi-centre pilot study. Acta Chir Belg. 2007 Nov-Dec;107(6):675-81. doi: 10.1080/00015458.2007.11680145.
Reference Type
BACKGROUND
van Rossum M, Vooijs DP, Walboomers XF, Hoekstra MJ, Spauwen PH, Jansen JA. The influence of a PHI-5-loaded silicone membrane, on cutaneous wound healing in vivo. J Mater Sci Mater Med. 2007 Jul;18(7):1449-56. doi: 10.1007/s10856-006-0112-z. Epub 2007 Mar 27.
Reference Type
BACKGROUND
Schmidtchen A, Wolff H, Hansson C. Differential proteinase expression by Pseudomonas aeruginosa derived from chronic leg ulcers. Acta Derm Venereol. 2001 Nov-Dec;81(6):406-9. doi: 10.1080/000155501317208336.
Reference Type
BACKGROUND
Edwards JV, Howley PS. Human neutrophil elastase and collagenase sequestration with phosphorylated cotton wound dressings. J Biomed Mater Res A. 2007 Nov;83(2):446-54. doi: 10.1002/jbm.a.31171.
Reference Type
BACKGROUND
Rushton I. Understanding the role of proteases and pH in wound healing. Nurs Stand. 2007 Apr 18-24;21(32):68, 70, 72 passim. doi: 10.7748/ns2007.04.21.32.68.c4499.
Reference Type
BACKGROUND
Gethin GT, Cowman S, Conroy RM. The impact of Manuka honey dressings on the surface pH of chronic wounds. Int Wound J. 2008 Jun;5(2):185-94. doi: 10.1111/j.1742-481X.2007.00424.x.
Reference Type
BACKGROUND
Wysocki AB, Staiano-Coico L, Grinnell F. Wound fluid from chronic leg ulcers contains elevated levels of metalloproteinases MMP-2 and MMP-9. J Invest Dermatol. 1993 Jul;101(1):64-8. doi: 10.1111/1523-1747.ep12359590.
Reference Type
BACKGROUND
Ravanti L, Kahari VM. Matrix metalloproteinases in wound repair (review). Int J Mol Med. 2000 Oct;6(4):391-407.
Reference Type
BACKGROUND
Muller M, Trocme C, Lardy B, Morel F, Halimi S, Benhamou PY. Matrix metalloproteinases and diabetic foot ulcers: the ratio of MMP-1 to TIMP-1 is a predictor of wound healing. Diabet Med. 2008 Apr;25(4):419-26. doi: 10.1111/j.1464-5491.2008.02414.x.
Reference Type
BACKGROUND
Schonfelder U, Abel M, Wiegand C, Klemm D, Elsner P, Hipler UC. Influence of selected wound dressings on PMN elastase in chronic wound fluid and their antioxidative potential in vitro. Biomaterials. 2005 Nov;26(33):6664-73. doi: 10.1016/j.biomaterials.2005.04.030.
Reference Type
BACKGROUND
Veves A, Sheehan P, Pham HT. A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. Arch Surg. 2002 Jul;137(7):822-7. doi: 10.1001/archsurg.137.7.822.
Reference Type
BACKGROUND
Smeets R, Ulrich D, Unglaub F, Woltje M, Pallua N. Effect of oxidised regenerated cellulose/collagen matrix on proteases in wound exudate of patients with chronic venous ulceration. Int Wound J. 2008 Jun;5(2):195-203. doi: 10.1111/j.1742-481X.2007.00367.x.
Reference Type
BACKGROUND
Lobmann R, Zemlin C, Motzkau M, Reschke K, Lehnert H. Expression of matrix metalloproteinases and growth factors in diabetic foot wounds treated with a protease absorbent dressing. J Diabetes Complications. 2006 Sep-Oct;20(5):329-35. doi: 10.1016/j.jdiacomp.2005.08.007.
Reference Type
BACKGROUND
Fasciglione GF, Marini S, D'Alessio S, Politi V, Coletta M. pH- and temperature-dependence of functional modulation in metalloproteinases. A comparison between neutrophil collagenase and gelatinases A and B. Biophys J. 2000 Oct;79(4):2138-49. doi: 10.1016/S0006-3495(00)76461-7.
Reference Type
BACKGROUND
Nwomeh BC, Liang HX, Cohen IK, Yager DR. MMP-8 is the predominant collagenase in healing wounds and nonhealing ulcers. J Surg Res. 1999 Feb;81(2):189-95. doi: 10.1006/jsre.1998.5495.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
05-011091
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
NCT07089602
RECRUITING
PHASE4
A Comparison of TCC-EZ Using Human Amnion Allograft vs TCC-EZ and Standard Wound Care in Treating Diabetic Foot Ulcers.
NCT02344329
UNKNOWN
PHASE4
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
NCT03662997
COMPLETED
NA
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
NCT04927702
TERMINATED
NA
Comparison of Wound Healing Between MedCu Dressings With Copper Oxide and Negative Pressure Wound Therapy Treatment
NCT05215730
COMPLETED
NA
Negative Pressure Wound Therapy vs Standard Care Dressing
NCT03566641
WITHDRAWN
NA
Clinical Evaluation of the SNaP Wound Care System in Promoting Healing in Chronic Wounds
NCT01417208
WITHDRAWN
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
NCT06437028
RECRUITING
NA
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
NCT01011387
COMPLETED
NA
Diabetic Foot Ulcer and Wound Infection
NCT03827902
WITHDRAWN
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
NCT00951080
COMPLETED
NA
Study Investigating the Safety and Efficacy of HP802-247 in the Treatment of Venous Leg Ulcers
NCT01656889
COMPLETED
PHASE3
Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
NCT07326553
RECRUITING
PHASE4
Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
NCT02071979
TERMINATED
NA
Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial
NCT05975827
NOT_YET_RECRUITING
NA
Evaluation of Cold Plasma in Chronic Wound Healing
NCT06964048
NOT_YET_RECRUITING
NA
A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers
NCT00235209
COMPLETED
PHASE4
Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.
NCT04687839
COMPLETED
NA
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.
NCT05632250
COMPLETED
NA
Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers
NCT02399826
UNKNOWN
NA
A REAL WORLD DATA COLLECTION OF HUMAN AMNIOTIC MEMBRANE(S) ON DIABETIC FOOT ULCERS, VENOUS LEG ULCERS, PRESSURE ULCERS AND POST OPERATIVE WOUNDS
NCT07078968
ACTIVE_NOT_RECRUITING
Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
NCT01143727
COMPLETED
PHASE4
Negative Pressure Wound Therapy in Traumatic Skin Loss
NCT05653297
UNKNOWN
Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers
NCT00512538
TERMINATED
PHASE3
Multiple Applications of ExpressGraft-C9T1 Skin Tissue as a Treatment for Diabetic Foot Ulcers
NCT04134143
TERMINATED
PHASE1