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A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers.

Abstract

HYPOTHESIS

Promogran, a wound dressing consisting of collagen and oxidized regenerated cellulose, is more effective that standard care in treating chronic diabetic plantar ulcers.

DESIGN

Randomized, prospective, controlled multicenter trial.

SETTING

University teaching hospitals and primary care centers.

PATIENTS

A total of 276 patients from 11 centers were enrolled in the study. The mean age of the patients was 58.3 years (range, 23-85 years). All patients had at least 1 diabetic foot ulcer.

INTERVENTIONS

Patients were randomized to receive Promogran (n = 138) or moistened gauze (control group; n = 138) and a secondary dressing. Dressings were changed when clinically required. The maximum follow-up for each patient was 12 weeks.

MAIN OUTCOME MEASURE

Complete healing of the study ulcer (wound).

RESULTS

After 12 weeks of treatment, 51 (37.0%) Promogran-treated patients had complete wound closure compared with 39 (28.3%) control patientss, but this difference was not statistically significant (P =.12). The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months' duration. In patients with ulcers of less than 6 months' duration, 43 (45%) of 95 Promogran-treated patients healed compared with 29 (33%) of 89 controls (P =.056). In the group with wounds of at least 6 months' duration, similar numbers of patients healed in the control (10/49 [20%]) and the Promogran (8/43 [19%]; P =.83) groups. No differences were seen in the safety measurements between groups. Patients and investigators expressed a strong preference for Promogran compared with moistened gauze.

CONCLUSIONS

Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance. Furthermore, Promogran had a safety profile that was similar to that of moistened gauze, with greater user satisfaction. Therefore, Promogran may be a useful adjunct in the management of diabetic foot ulceration, especially in ulcers of less than 6 months' duration.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Joslin Beth Israel Deaconess Foot Center, One Deaconess Rd, Boston, MA 02215, USA. aveves@caregroup.harvard.edu

    ,

    Source

    MeSH

    Adult
    Aged
    Aged, 80 and over
    Bandages
    Cellulose, Oxidized
    Collagen
    Diabetic Foot
    Female
    Hemostatics
    Humans
    Male
    Middle Aged
    Prospective Studies
    Treatment Outcome
    Wound Healing

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    12093340

    Citation

    Veves, Aristidis, et al. "A Randomized, Controlled Trial of Promogran (a Collagen/oxidized Regenerated Cellulose Dressing) Vs Standard Treatment in the Management of Diabetic Foot Ulcers." Archives of Surgery (Chicago, Ill. : 1960), vol. 137, no. 7, 2002, pp. 822-7.
    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;137(7):822-7.
    Veves, A., Sheehan, P., & Pham, H. T. (2002). A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. Archives of Surgery (Chicago, Ill. : 1960), 137(7), pp. 822-7.
    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;137(7):822-7. PubMed PMID: 12093340.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. AU - Veves,Aristidis, AU - Sheehan,Peter, AU - Pham,Hau T, PY - 2002/7/3/pubmed PY - 2002/8/3/medline PY - 2002/7/3/entrez SP - 822 EP - 7 JF - Archives of surgery (Chicago, Ill. : 1960) JO - Arch Surg VL - 137 IS - 7 N2 - HYPOTHESIS: Promogran, a wound dressing consisting of collagen and oxidized regenerated cellulose, is more effective that standard care in treating chronic diabetic plantar ulcers. DESIGN: Randomized, prospective, controlled multicenter trial. SETTING: University teaching hospitals and primary care centers. PATIENTS: A total of 276 patients from 11 centers were enrolled in the study. The mean age of the patients was 58.3 years (range, 23-85 years). All patients had at least 1 diabetic foot ulcer. INTERVENTIONS: Patients were randomized to receive Promogran (n = 138) or moistened gauze (control group; n = 138) and a secondary dressing. Dressings were changed when clinically required. The maximum follow-up for each patient was 12 weeks. MAIN OUTCOME MEASURE: Complete healing of the study ulcer (wound). RESULTS: After 12 weeks of treatment, 51 (37.0%) Promogran-treated patients had complete wound closure compared with 39 (28.3%) control patientss, but this difference was not statistically significant (P =.12). The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months' duration. In patients with ulcers of less than 6 months' duration, 43 (45%) of 95 Promogran-treated patients healed compared with 29 (33%) of 89 controls (P =.056). In the group with wounds of at least 6 months' duration, similar numbers of patients healed in the control (10/49 [20%]) and the Promogran (8/43 [19%]; P =.83) groups. No differences were seen in the safety measurements between groups. Patients and investigators expressed a strong preference for Promogran compared with moistened gauze. CONCLUSIONS: Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers. It showed an additional efficacy for ulcers of less than 6 months' duration that was of marginal statistical significance. Furthermore, Promogran had a safety profile that was similar to that of moistened gauze, with greater user satisfaction. Therefore, Promogran may be a useful adjunct in the management of diabetic foot ulceration, especially in ulcers of less than 6 months' duration. SN - 0004-0010 UR - https://www.unboundmedicine.com/medline/citation/12093340/A_randomized_controlled_trial_of_Promogran__a_collagen/oxidized_regenerated_cellulose_dressing__vs_standard_treatment_in_the_management_of_diabetic_foot_ulcers_ L2 - https://jamanetwork.com/journals/jamasurgery/fullarticle/vol/137/pg/822 DB - PRIME DP - Unbound Medicine ER -