The clinical and histological effects of Dermagraft® in the healing of chronic venous leg ulcers

Latha Krishnamoorthy, Keith Harding, David Griffiths, Keith Moore, David Leaper, Keith Poskitt, R. Gary Sibbald, Alain Brassard, Kenneth Dolynchuk, Julian Adams, Mark Whyman

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Objective: Pilot study to assess the safety and effectiveness of Dermagraft® when used in conjunction with multi-layer compression bandage therapy (Profore™) compared with multilayer compression only in the treatment of chronic venous leg ulcers. Design: Open-label, prospective, multicentre, randomized, controlled clinical trial. Methods: Patients aged at least 18 years with leg ulceration of venous aetiology were screened for inclusion in the trial. Patients with arterial disease (ankle brachial pressure index <0.7) and causes of ulceration other than venous disease were excluded. Patients were randomized into four groups. Three active treatment groups received Dermagraft® in combination with compression bandaging, Profore™: Group 1, 12 pieces of Dermagraft (one per week for 12 weeks); Group 2, four pieces of Dermagraft (Weeks 0, 1, 4, 8); Group 3, one piece of Dermagraft (Week 0). The control group was treated with compression bandaging alone (Group 4). The study was not powered to detect statistical differences in healing rates. Adverse events were reported according to national guidelines. There was no statistical analysis of adverse event data. Results: In all 53 patients were randomized, of whom 47 completed the study per protocol. At 12 weeks complete healing of the ulcer, analysed by 'intention-to-treat' (ITT) was 15% using Profore alone, 7% using single application Dermagraft and Profore (Group 3), compared with 38% using multiple applications of Dermagraft and Profore (Groups 1 and 2). At study discontinuation, the median percentage reduction in wound area was 81.4% for Group 1, 88.6% for Group 2, 59.4% for Group 3 and 78.1% for Group 4. No major safety issues were identified during the course of the study. Conclusions: The results of the pilot study indicate that four pieces of Dermagraft are the optimal application frequency to take forward to further clinical trials. Further studies are required to confirm these data, and these should be powered to detect whether there are statistical differences in healing rates and safety between different regimens.

Original languageEnglish (US)
Pages (from-to)12-22
Number of pages11
JournalPhlebology
Volume18
Issue number1
DOIs
StatePublished - Mar 25 2003
Externally publishedYes

Fingerprint

Varicose Ulcer
Leg Ulcer
Safety
Compression Bandages
Ankle Brachial Index
Ulcer
Leg
Therapeutics
Randomized Controlled Trials
Clinical Trials
Guidelines
Pressure
Control Groups
Wounds and Injuries

Keywords

  • Chronic venous leg ulcer
  • Human dermal replacement
  • Multi-layer compression therapy
  • Randomized clinical trial

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Krishnamoorthy, L., Harding, K., Griffiths, D., Moore, K., Leaper, D., Poskitt, K., ... Whyman, M. (2003). The clinical and histological effects of Dermagraft® in the healing of chronic venous leg ulcers. Phlebology, 18(1), 12-22. https://doi.org/10.1258/026835503321236858

The clinical and histological effects of Dermagraft® in the healing of chronic venous leg ulcers. / Krishnamoorthy, Latha; Harding, Keith; Griffiths, David; Moore, Keith; Leaper, David; Poskitt, Keith; Sibbald, R. Gary; Brassard, Alain; Dolynchuk, Kenneth; Adams, Julian; Whyman, Mark.

In: Phlebology, Vol. 18, No. 1, 25.03.2003, p. 12-22.

Research output: Contribution to journalArticle

Krishnamoorthy, L, Harding, K, Griffiths, D, Moore, K, Leaper, D, Poskitt, K, Sibbald, RG, Brassard, A, Dolynchuk, K, Adams, J & Whyman, M 2003, 'The clinical and histological effects of Dermagraft® in the healing of chronic venous leg ulcers', Phlebology, vol. 18, no. 1, pp. 12-22. https://doi.org/10.1258/026835503321236858
Krishnamoorthy L, Harding K, Griffiths D, Moore K, Leaper D, Poskitt K et al. The clinical and histological effects of Dermagraft® in the healing of chronic venous leg ulcers. Phlebology. 2003 Mar 25;18(1):12-22. https://doi.org/10.1258/026835503321236858
Krishnamoorthy, Latha ; Harding, Keith ; Griffiths, David ; Moore, Keith ; Leaper, David ; Poskitt, Keith ; Sibbald, R. Gary ; Brassard, Alain ; Dolynchuk, Kenneth ; Adams, Julian ; Whyman, Mark. / The clinical and histological effects of Dermagraft® in the healing of chronic venous leg ulcers. In: Phlebology. 2003 ; Vol. 18, No. 1. pp. 12-22.
@article{9c6fc2a4ba254d5eaf0378735cf37331,
title = "The clinical and histological effects of Dermagraft{\circledR} in the healing of chronic venous leg ulcers",
abstract = "Objective: Pilot study to assess the safety and effectiveness of Dermagraft{\circledR} when used in conjunction with multi-layer compression bandage therapy (Profore™) compared with multilayer compression only in the treatment of chronic venous leg ulcers. Design: Open-label, prospective, multicentre, randomized, controlled clinical trial. Methods: Patients aged at least 18 years with leg ulceration of venous aetiology were screened for inclusion in the trial. Patients with arterial disease (ankle brachial pressure index <0.7) and causes of ulceration other than venous disease were excluded. Patients were randomized into four groups. Three active treatment groups received Dermagraft{\circledR} in combination with compression bandaging, Profore™: Group 1, 12 pieces of Dermagraft (one per week for 12 weeks); Group 2, four pieces of Dermagraft (Weeks 0, 1, 4, 8); Group 3, one piece of Dermagraft (Week 0). The control group was treated with compression bandaging alone (Group 4). The study was not powered to detect statistical differences in healing rates. Adverse events were reported according to national guidelines. There was no statistical analysis of adverse event data. Results: In all 53 patients were randomized, of whom 47 completed the study per protocol. At 12 weeks complete healing of the ulcer, analysed by 'intention-to-treat' (ITT) was 15{\%} using Profore alone, 7{\%} using single application Dermagraft and Profore (Group 3), compared with 38{\%} using multiple applications of Dermagraft and Profore (Groups 1 and 2). At study discontinuation, the median percentage reduction in wound area was 81.4{\%} for Group 1, 88.6{\%} for Group 2, 59.4{\%} for Group 3 and 78.1{\%} for Group 4. No major safety issues were identified during the course of the study. Conclusions: The results of the pilot study indicate that four pieces of Dermagraft are the optimal application frequency to take forward to further clinical trials. Further studies are required to confirm these data, and these should be powered to detect whether there are statistical differences in healing rates and safety between different regimens.",
keywords = "Chronic venous leg ulcer, Human dermal replacement, Multi-layer compression therapy, Randomized clinical trial",
author = "Latha Krishnamoorthy and Keith Harding and David Griffiths and Keith Moore and David Leaper and Keith Poskitt and Sibbald, {R. Gary} and Alain Brassard and Kenneth Dolynchuk and Julian Adams and Mark Whyman",
year = "2003",
month = "3",
day = "25",
doi = "10.1258/026835503321236858",
language = "English (US)",
volume = "18",
pages = "12--22",
journal = "Phlebology",
issn = "1433-3031",
publisher = "SAGE Publications Ltd",
number = "1",

}

TY - JOUR

T1 - The clinical and histological effects of Dermagraft® in the healing of chronic venous leg ulcers

AU - Krishnamoorthy, Latha

AU - Harding, Keith

AU - Griffiths, David

AU - Moore, Keith

AU - Leaper, David

AU - Poskitt, Keith

AU - Sibbald, R. Gary

AU - Brassard, Alain

AU - Dolynchuk, Kenneth

AU - Adams, Julian

AU - Whyman, Mark

PY - 2003/3/25

Y1 - 2003/3/25

N2 - Objective: Pilot study to assess the safety and effectiveness of Dermagraft® when used in conjunction with multi-layer compression bandage therapy (Profore™) compared with multilayer compression only in the treatment of chronic venous leg ulcers. Design: Open-label, prospective, multicentre, randomized, controlled clinical trial. Methods: Patients aged at least 18 years with leg ulceration of venous aetiology were screened for inclusion in the trial. Patients with arterial disease (ankle brachial pressure index <0.7) and causes of ulceration other than venous disease were excluded. Patients were randomized into four groups. Three active treatment groups received Dermagraft® in combination with compression bandaging, Profore™: Group 1, 12 pieces of Dermagraft (one per week for 12 weeks); Group 2, four pieces of Dermagraft (Weeks 0, 1, 4, 8); Group 3, one piece of Dermagraft (Week 0). The control group was treated with compression bandaging alone (Group 4). The study was not powered to detect statistical differences in healing rates. Adverse events were reported according to national guidelines. There was no statistical analysis of adverse event data. Results: In all 53 patients were randomized, of whom 47 completed the study per protocol. At 12 weeks complete healing of the ulcer, analysed by 'intention-to-treat' (ITT) was 15% using Profore alone, 7% using single application Dermagraft and Profore (Group 3), compared with 38% using multiple applications of Dermagraft and Profore (Groups 1 and 2). At study discontinuation, the median percentage reduction in wound area was 81.4% for Group 1, 88.6% for Group 2, 59.4% for Group 3 and 78.1% for Group 4. No major safety issues were identified during the course of the study. Conclusions: The results of the pilot study indicate that four pieces of Dermagraft are the optimal application frequency to take forward to further clinical trials. Further studies are required to confirm these data, and these should be powered to detect whether there are statistical differences in healing rates and safety between different regimens.

AB - Objective: Pilot study to assess the safety and effectiveness of Dermagraft® when used in conjunction with multi-layer compression bandage therapy (Profore™) compared with multilayer compression only in the treatment of chronic venous leg ulcers. Design: Open-label, prospective, multicentre, randomized, controlled clinical trial. Methods: Patients aged at least 18 years with leg ulceration of venous aetiology were screened for inclusion in the trial. Patients with arterial disease (ankle brachial pressure index <0.7) and causes of ulceration other than venous disease were excluded. Patients were randomized into four groups. Three active treatment groups received Dermagraft® in combination with compression bandaging, Profore™: Group 1, 12 pieces of Dermagraft (one per week for 12 weeks); Group 2, four pieces of Dermagraft (Weeks 0, 1, 4, 8); Group 3, one piece of Dermagraft (Week 0). The control group was treated with compression bandaging alone (Group 4). The study was not powered to detect statistical differences in healing rates. Adverse events were reported according to national guidelines. There was no statistical analysis of adverse event data. Results: In all 53 patients were randomized, of whom 47 completed the study per protocol. At 12 weeks complete healing of the ulcer, analysed by 'intention-to-treat' (ITT) was 15% using Profore alone, 7% using single application Dermagraft and Profore (Group 3), compared with 38% using multiple applications of Dermagraft and Profore (Groups 1 and 2). At study discontinuation, the median percentage reduction in wound area was 81.4% for Group 1, 88.6% for Group 2, 59.4% for Group 3 and 78.1% for Group 4. No major safety issues were identified during the course of the study. Conclusions: The results of the pilot study indicate that four pieces of Dermagraft are the optimal application frequency to take forward to further clinical trials. Further studies are required to confirm these data, and these should be powered to detect whether there are statistical differences in healing rates and safety between different regimens.

KW - Chronic venous leg ulcer

KW - Human dermal replacement

KW - Multi-layer compression therapy

KW - Randomized clinical trial

UR - http://www.scopus.com/inward/record.url?scp=0037227544&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037227544&partnerID=8YFLogxK

U2 - 10.1258/026835503321236858

DO - 10.1258/026835503321236858

M3 - Article

VL - 18

SP - 12

EP - 22

JO - Phlebology

JF - Phlebology

SN - 1433-3031

IS - 1

ER -